Johnson & Johnson (JNJ)
FDA Applications
Note: This list only includes applications that have been responded to by the FDA.
| Application | Product Name | Active Ingredient | Form | Strength | Status | ||
|---|---|---|---|---|---|---|---|
| BLA761342 - JANSSEN BIOTECH | |||||||
| TALVEY | TALQUETAMAB-TGVS | INJECTABLE;INJECTION | 3MG/1.5ML(2MG/ML) | Prescription | |||
| TALVEY | TALQUETAMAB-TGVS | INJECTABLE;INJECTION | 40MG/ML | Prescription | |||
| BLA761291 - JANSSEN BIOTECH | |||||||
| TECVAYLI | TECLISTAMAB-CQYV | INJECTABLE;INJECTION | 30MG/3ML(10MG/ML) | Prescription | |||
| TECVAYLI | TECLISTAMAB-CQYV | INJECTABLE;INJECTION | 153MG/1.7ML(90MG/ML) | Prescription | |||
| BLA761210 - JANSSEN BIOTECH | |||||||
| RYBREVANT | AMIVANTAMAB-VMJW | INJECTABLE;INJECTION | 350MG/7ML(50MG/ML) | Prescription | |||
| BLA761145 - JANSSEN BIOTECH | |||||||
| DARZALEX FASPRO | DARATUMUMAB AND HYALURONIDASE-FIHJ | INJECTABLE;INJECTION | 120MG;2000UNITS/ML | Prescription | |||
| BLA761061 - JANSSEN BIOTECH | |||||||
| TREMFYA | GUSELKUMAB | INJECTABLE;INJECTION | 100MG/ML | Prescription | |||
| BLA761044 - JANSSEN BIOTECH | |||||||
| STELARA | USTEKINUMAB | INJECTABLE;INJECTION | 130MG/26ML | Prescription | |||
| BLA761036 - JANSSEN BIOTECH | |||||||
| DARZALEX | DARATUMUMAB | INJECTABLE;INJECTION | 100MG/5ML | Prescription | |||
| DARZALEX | DARATUMUMAB | INJECTABLE;INJECTION | 400MG/20ML | Prescription | |||
| NDA219016 - JANSSEN PRODS | |||||||
| EDURANT PED | RILPIVIRINE HYDROCHLORIDE | TABLET, FOR SUSPENSION;ORAL | EQ 2.5MG BASE | Discontinued | |||
| NDA219008 - JANSSEN BIOTECH | |||||||
| LAZCLUZE | LAZERTINIB MESYLATE | TABLET;ORAL | EQ 80MG BASE | Prescription | |||
| LAZCLUZE | LAZERTINIB MESYLATE | TABLET;ORAL | EQ 240MG BASE | Prescription | |||
| NDA217603 - TARSUS | |||||||
| XDEMVY | LOTILANER | SOLUTION/DROPS;OPHTHALMIC | 0.25% | Prescription | |||
| NDA216793 - JANSSEN BIOTECH | |||||||
| AKEEGA | ABIRATERONE ACETATE; NIRAPARIB TOSYLATE | TABLET;ORAL | 500MG;EQ 50MG BASE | Prescription | |||
| AKEEGA | ABIRATERONE ACETATE; NIRAPARIB TOSYLATE | TABLET;ORAL | 500MG;EQ 100MG BASE | Prescription | |||
| NDA215859 - JANSSEN PHARMS | |||||||
| XARELTO | RIVAROXABAN | FOR SUSPENSION;ORAL | 1MG/ML | Prescription | |||
| NDA212018 - JANSSEN BIOTECH | |||||||
| BALVERSA | ERDAFITINIB | TABLET;ORAL | 5MG | Prescription | |||
| BALVERSA | ERDAFITINIB | TABLET;ORAL | 4MG | Prescription | |||
| BALVERSA | ERDAFITINIB | TABLET;ORAL | 3MG | Prescription | |||
| NDA211243 - JANSSEN PHARMS | |||||||
| SPRAVATO | ESKETAMINE HYDROCHLORIDE | SPRAY;NASAL | EQ 28MG BASE | Prescription | |||
| NDA210951 - JANSSEN BIOTECH | |||||||
| ERLEADA | APALUTAMIDE | TABLET;ORAL | 240MG | Prescription | |||
| ERLEADA | APALUTAMIDE | TABLET;ORAL | 60MG | Prescription | |||
| NDA210455 - JANSSEN PRODS | |||||||
| SYMTUZA | COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE | TABLET;ORAL | 150MG;800MG;200MG;EQ 10MG BASE | Prescription | |||
| NDA208398 - JANSSEN PHARMS | |||||||
| VERMOX | MEBENDAZOLE | TABLET, CHEWABLE;ORAL | 500MG | Discontinued | |||
| NDA207953 - JANSSEN PRODS | |||||||
| YONDELIS | TRABECTEDIN | POWDER;INTRAVENOUS | 1MG/VIAL | Prescription | |||
| NDA207946 - JANSSEN PHARMS | |||||||
| INVEGA TRINZA | PALIPERIDONE PALMITATE | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 273MG/0.875ML (273MG/0.875ML) | Prescription | |||
| INVEGA TRINZA | PALIPERIDONE PALMITATE | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 410MG/1.315ML (311.79MG/ML) | Prescription | |||
| INVEGA TRINZA | PALIPERIDONE PALMITATE | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 546MG/1.75ML (312MG/ML) | Prescription | |||
| INVEGA TRINZA | PALIPERIDONE PALMITATE | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 819MG/2.625ML (312MG/ML) | Prescription | |||
| INVEGA HAFYERA | PALIPERIDONE PALMITATE | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 1.092GM/3.5ML (312MG/ML) | Prescription | |||
| INVEGA HAFYERA | PALIPERIDONE PALMITATE | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 1.560GM/5ML (312MG/ML) | Prescription | |||
| NDA205879 - JANSSEN PHARMS | |||||||
| INVOKAMET XR | CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 50MG;500MG | Prescription | |||
| INVOKAMET XR | CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 50MG;1GM | Prescription | |||
| INVOKAMET XR | CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 150MG;500MG | Prescription | |||
| INVOKAMET XR | CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 150MG;1GM | Prescription | |||
| NDA205395 - JANSSEN PRODS | |||||||
| PREZCOBIX | COBICISTAT; DARUNAVIR | TABLET;ORAL | 150MG;800MG | Prescription | |||
| NDA205123 - JANSSEN PRODS | |||||||
| OLYSIO | SIMEPREVIR SODIUM | CAPSULE;ORAL | EQ 150MG BASE | Discontinued | |||
| NDA204384 - JANSSEN THERAP | |||||||
| SIRTURO | BEDAQUILINE FUMARATE | TABLET;ORAL | EQ 20MG BASE | Prescription | |||
| SIRTURO | BEDAQUILINE FUMARATE | TABLET;ORAL | EQ 100MG BASE | Prescription | |||
| NDA204353 - JANSSEN PHARMS | |||||||
| INVOKAMET | CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET;ORAL | 50MG;500MG | Prescription | |||
| INVOKAMET | CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET;ORAL | 50MG;1GM | Prescription | |||
| INVOKAMET | CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET;ORAL | 150MG;500MG | Prescription | |||
| INVOKAMET | CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET;ORAL | 150MG;1GM | Prescription | |||
| NDA204042 - JANSSEN PHARMS | |||||||
| INVOKANA | CANAGLIFLOZIN | TABLET;ORAL | 300MG | Prescription | |||
| INVOKANA | CANAGLIFLOZIN | TABLET;ORAL | 100MG | Prescription | |||
| NDA202895 - JANSSEN PRODS | |||||||
| PREZISTA | DARUNAVIR | SUSPENSION;ORAL | 100MG/ML | Prescription | |||
| NDA202439 - JANSSEN PHARMS | |||||||
| XARELTO | RIVAROXABAN | TABLET;ORAL | 15MG | Prescription | |||
| XARELTO | RIVAROXABAN | TABLET;ORAL | 20MG | Prescription | |||
| XARELTO | RIVAROXABAN | TABLET;ORAL | 2.5MG | Prescription | |||
| XARELTO | RIVAROXABAN | TABLET;ORAL | 10MG | Prescription | |||
| NDA202379 - JANSSEN BIOTECH | |||||||
| ZYTIGA | ABIRATERONE ACETATE | TABLET;ORAL | 500MG | Prescription | |||
| ZYTIGA | ABIRATERONE ACETATE | TABLET;ORAL | 250MG | Prescription | |||
| NDA202022 - JANSSEN PRODS | |||||||
| EDURANT | RILPIVIRINE HYDROCHLORIDE | TABLET;ORAL | EQ 25MG BASE | Prescription | |||
| BLA125433 - JANSSEN BIOTECH | |||||||
| SIMPONI ARIA | GOLIMUMAB | INJECTABLE; INJECTION | 50MG/4ML | Prescription | |||
| ANDA088790 - JANSSEN PHARMS | |||||||
| TYLOX | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | CAPSULE;ORAL | 500MG;5MG | Discontinued | |||
| ANDA085055 - JANSSEN PHARMS | |||||||
| TYLENOL W/ CODEINE NO. 1 | ACETAMINOPHEN; CODEINE PHOSPHATE | TABLET;ORAL | 300MG;7.5MG | Discontinued | |||
| TYLENOL W/ CODEINE NO. 2 | ACETAMINOPHEN; CODEINE PHOSPHATE | TABLET;ORAL | 300MG;15MG | Discontinued | |||
| TYLENOL W/ CODEINE NO. 3 | ACETAMINOPHEN; CODEINE PHOSPHATE | TABLET;ORAL | 300MG;30MG | Discontinued | |||
| TYLENOL W/ CODEINE NO. 4 | ACETAMINOPHEN; CODEINE PHOSPHATE | TABLET;ORAL | 300MG;60MG | Discontinued | |||
| ANDA070767 - JANSSEN PHARMA | |||||||
| NIZORAL | KETOCONAZOLE | SUSPENSION;ORAL | 100MG/5ML | Discontinued | |||
| ANDA070081 - J AND J CONSUMER INC | |||||||
| IBUPROFEN | IBUPROFEN | TABLET;ORAL | 400MG | Discontinued | |||
| NDA050594 - JOHNSON AND JOHNSON | |||||||
| ERYCETTE | ERYTHROMYCIN | SWAB;TOPICAL | 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA050518 - JOHNSON AND JOHNSON | |||||||
| MECLAN | MECLOCYCLINE SULFOSALICYLATE | CREAM;TOPICAL | 1% | Discontinued | |||
| NDA050448 - JOHNSON AND JOHNSON | |||||||
| GRIFULVIN V | GRISEOFULVIN, MICROCRYSTALLINE | SUSPENSION;ORAL | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA022578 - KENVUE BRANDS | |||||||
| ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | TABLET, ORALLY DISINTEGRATING;ORAL | 10MG | Over-the-counter | |||
| NDA022406 - JANSSEN PHARMS | |||||||
| XARELTO | RIVAROXABAN | TABLET;ORAL | 15MG | Prescription | |||
| XARELTO | RIVAROXABAN | TABLET;ORAL | 20MG | Prescription | |||
| XARELTO | RIVAROXABAN | TABLET;ORAL | 2.5MG | Prescription | |||
| XARELTO | RIVAROXABAN | TABLET;ORAL | 10MG | Prescription | |||
| NDA022388 - JOHNSON JOHNSON VISN | |||||||
| ACUVUE THERAVISION WITH KETOTIFEN | KETOTIFEN FUMARATE | DRUG-ELUTING CONTACT LENS;OPHTHALMIC | EQ 19MCG BASE | Discontinued | |||
| NDA022264 - JANSSEN PHARMS | |||||||
| INVEGA SUSTENNA | PALIPERIDONE PALMITATE | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 39MG/0.25ML (39MG/0.25ML) | Prescription | |||
| INVEGA SUSTENNA | PALIPERIDONE PALMITATE | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 78MG/0.5ML (78MG/0.5ML) | Prescription | |||
| INVEGA SUSTENNA | PALIPERIDONE PALMITATE | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 117MG/0.75ML (117MG/0.75ML) | Prescription | |||
| INVEGA SUSTENNA | PALIPERIDONE PALMITATE | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 156MG/ML (156MG/ML) | Prescription | |||
| INVEGA SUSTENNA | PALIPERIDONE PALMITATE | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 234MG/1.5ML (156MG/ML) | Prescription | |||
| NDA022187 - JANSSEN R AND D | |||||||
| INTELENCE | ETRAVIRINE | TABLET;ORAL | 25MG | Prescription | |||
| INTELENCE | ETRAVIRINE | TABLET;ORAL | 200MG | Prescription | |||
| INTELENCE | ETRAVIRINE | TABLET;ORAL | 100MG | Prescription | |||
| NDA022155 - KENVUE BRANDS | |||||||
| CHILDREN'S ZYRTEC HIVES | CETIRIZINE HYDROCHLORIDE | SOLUTION;ORAL | 5MG/5ML | Over-the-counter | |||
| CHILDREN'S ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | SOLUTION;ORAL | 5MG/5ML | Over-the-counter | |||
| NDA022043 - JANSSEN LP | |||||||
| INVEGA | PALIPERIDONE | TABLET, EXTENDED RELEASE; ORAL | 6MG | Prescription | |||
| INVEGA | PALIPERIDONE | TABLET, EXTENDED RELEASE; ORAL | 12MG | Prescription | |||
| INVEGA | PALIPERIDONE | TABLET, EXTENDED RELEASE; ORAL | 9MG | Prescription | |||
| INVEGA | PALIPERIDONE | TABLET, EXTENDED RELEASE; ORAL | 3MG | Prescription | |||
| NDA021999 - JANSSEN PHARMS | |||||||
| INVEGA | PALIPERIDONE | TABLET, EXTENDED RELEASE;ORAL | 6MG | Prescription | |||
| INVEGA | PALIPERIDONE | TABLET, EXTENDED RELEASE;ORAL | 9MG | Prescription | |||
| INVEGA | PALIPERIDONE | TABLET, EXTENDED RELEASE;ORAL | 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| INVEGA | PALIPERIDONE | TABLET, EXTENDED RELEASE;ORAL | 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| INVEGA | PALIPERIDONE | TABLET, EXTENDED RELEASE;ORAL | 3MG | Prescription | |||
| NDA021976 - JANSSEN PRODS | |||||||
| PREZISTA | DARUNAVIR | TABLET;ORAL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| PREZISTA | DARUNAVIR | TABLET;ORAL | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| PREZISTA | DARUNAVIR | TABLET;ORAL | 800MG | Prescription | |||
| PREZISTA | DARUNAVIR | TABLET;ORAL | 600MG | Prescription | |||
| PREZISTA | DARUNAVIR | TABLET;ORAL | 150MG | Prescription | |||
| PREZISTA | DARUNAVIR | TABLET;ORAL | 75MG | Prescription | |||
| NDA021812 - KENVUE BRANDS | |||||||
| MEN'S ROGAINE | MINOXIDIL | AEROSOL, FOAM;TOPICAL | 5% | Over-the-counter | |||
| WOMEN'S ROGAINE | MINOXIDIL | AEROSOL, FOAM;TOPICAL | 5% | Over-the-counter | |||
| NDA021721 - JANSSEN PHARMS | |||||||
| LEVAQUIN | LEVOFLOXACIN | SOLUTION;ORAL | 250MG/10ML | Discontinued | |||
| NDA021621 - KENVUE BRANDS | |||||||
| CHILDREN'S ZYRTEC HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | TABLET, CHEWABLE;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| CHILDREN'S ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | TABLET, CHEWABLE;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| CHILDREN'S ZYRTEC HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | TABLET, CHEWABLE;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| CHILDREN'S ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | TABLET, CHEWABLE;ORAL | 10MG | Over-the-counter | |||
| CHILDREN'S ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | TABLET, CHEWABLE;ORAL | 2.5MG | Over-the-counter | |||
| NDA021615 - JANSSEN PHARMS | |||||||
| RAZADYNE ER | GALANTAMINE HYDROBROMIDE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 16MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| RAZADYNE ER | GALANTAMINE HYDROBROMIDE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| RAZADYNE ER | GALANTAMINE HYDROBROMIDE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA021444 - JANSSEN PHARMS | |||||||
| RISPERDAL | RISPERIDONE | TABLET, ORALLY DISINTEGRATING;ORAL | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| RISPERDAL | RISPERIDONE | TABLET, ORALLY DISINTEGRATING;ORAL | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| RISPERDAL | RISPERIDONE | TABLET, ORALLY DISINTEGRATING;ORAL | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| RISPERDAL | RISPERIDONE | TABLET, ORALLY DISINTEGRATING;ORAL | 3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| RISPERDAL | RISPERIDONE | TABLET, ORALLY DISINTEGRATING;ORAL | 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA021346 - JANSSEN PHARMS | |||||||
| RISPERDAL CONSTA | RISPERIDONE | INJECTABLE;INTRAMUSCULAR | 25MG/VIAL | Prescription | |||
| RISPERDAL CONSTA | RISPERIDONE | INJECTABLE;INTRAMUSCULAR | 37.5MG/VIAL | Prescription | |||
| RISPERDAL CONSTA | RISPERIDONE | INJECTABLE;INTRAMUSCULAR | 50MG/VIAL | Prescription | |||
| RISPERDAL CONSTA | RISPERIDONE | INJECTABLE;INTRAMUSCULAR | 12.5MG/VIAL | Prescription | |||
| NDA021241 - JANSSEN PHARMS | |||||||
| ORTHO TRI-CYCLEN LO | ETHINYL ESTRADIOL; NORGESTIMATE | TABLET;ORAL-28 | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA021224 - JANSSEN PHARMS | |||||||
| RAZADYNE | GALANTAMINE HYDROBROMIDE | SOLUTION;ORAL | 4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA021180 - JANSSEN PHARMS | |||||||
| ORTHO EVRA | ETHINYL ESTRADIOL; NORELGESTROMIN | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.035MG/24HR;0.15MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA021169 - JANSSEN PHARMS | |||||||
| RAZADYNE | GALANTAMINE HYDROBROMIDE | TABLET;ORAL | EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| RAZADYNE | GALANTAMINE HYDROBROMIDE | TABLET;ORAL | EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| RAZADYNE | GALANTAMINE HYDROBROMIDE | TABLET;ORAL | EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA021150 - KENVUE BRANDS | |||||||
| ZYRTEC-D 12 HOUR | CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 5MG;120MG | Over-the-counter | |||
| NDA021140 - KENVUE BRANDS | |||||||
| IMODIUM MULTI-SYMPTOM RELIEF | LOPERAMIDE HYDROCHLORIDE; SIMETHICONE | TABLET;ORAL | 2MG;125MG | Over-the-counter | |||
| NDA021128 - KENVUE BRANDS | |||||||
| CHILDREN'S MOTRIN COLD | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | SUSPENSION;ORAL | 100MG/5ML;15MG/5ML | Over-the-counter | |||
| NDA021123 - JANSSEN PHARMS | |||||||
| ULTRACET | ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE | TABLET;ORAL | 325MG;37.5MG | Discontinued | |||
| NDA021121 - JANSSEN PHARMS | |||||||
| CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 18MG | Prescription | |||
| CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 36MG | Prescription | |||
| CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 54MG | Prescription | |||
| CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 27MG | Prescription | |||
| NDA021088 - ORTHO MCNEIL JANSSEN | |||||||
| VIADUR | LEUPROLIDE ACETATE | IMPLANT;IMPLANTATION | EQ 65MG BASE | Discontinued | |||
| NDA021001 - JANSSEN PHARMS | |||||||
| AXERT | ALMOTRIPTAN MALATE | TABLET;ORAL | EQ 6.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| AXERT | ALMOTRIPTAN MALATE | TABLET;ORAL | EQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA020966 - JANSSEN PHARMS | |||||||
| SPORANOX | ITRACONAZOLE | INJECTABLE;INJECTION | 10MG/ML | Discontinued | |||
| NDA020958 - KENVUE BRANDS | |||||||
| PEPCID COMPLETE | CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE | TABLET, CHEWABLE;ORAL | 800MG;10MG;165MG | Over-the-counter | |||
| NDA020902 - J AND J CONSUMER INC | |||||||
| PEPCID AC | FAMOTIDINE | TABLET;ORAL | 10MG | Over-the-counter | |||
| NDA020897 - JANSSEN PHARMS | |||||||
| DITROPAN XL | OXYBUTYNIN CHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| DITROPAN XL | OXYBUTYNIN CHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| DITROPAN XL | OXYBUTYNIN CHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA020844 - JANSSEN PHARMS | |||||||
| TOPAMAX | TOPIRAMATE | CAPSULE;ORAL | 25MG | Prescription | |||
| TOPAMAX SPRINKLE | TOPIRAMATE | CAPSULE;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| TOPAMAX | TOPIRAMATE | CAPSULE;ORAL | 15MG | Prescription | |||
| NDA020834 - KENVUE BRANDS | |||||||
| ROGAINE EXTRA STRENGTH (FOR MEN) | MINOXIDIL | SOLUTION;TOPICAL | 5% | Over-the-counter | |||
| NDA020801 - KENVUE BRANDS | |||||||
| PEPCID AC | FAMOTIDINE | TABLET, CHEWABLE;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| PEPCID AC | FAMOTIDINE | TABLET, CHEWABLE;ORAL | 20MG | Over-the-counter | |||
| NDA020767 - JANSSEN PHARMA | |||||||
| PROPULSID QUICKSOLV | CISAPRIDE MONOHYDRATE | TABLET, ORALLY DISINTEGRATING;ORAL | EQ 20MG BASE | Discontinued | |||
| NDA020746 - KENVUE BRANDS | |||||||
| RHINOCORT | BUDESONIDE | SPRAY, METERED;NASAL | 0.064MG/INH | Discontinued | |||
| RHINOCORT ALLERGY | BUDESONIDE | SPRAY, METERED;NASAL | 0.032MG/SPRAY | Over-the-counter | |||
| RHINOCORT | BUDESONIDE | SPRAY, METERED;NASAL | 0.032MG/INH | Prescription | |||
| NDA020694 - JANSSEN PHARMA | |||||||
| SPORANOX | ITRACONAZOLE | CAPSULE; ORAL | 100MG | Prescription | |||
| NDA020657 - JANSSEN PHARMS | |||||||
| SPORANOX | ITRACONAZOLE | SOLUTION;ORAL | 10MG/ML | Prescription | |||
| NDA020635 - JANSSEN PHARMS | |||||||
| LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | INJECTABLE;INJECTION | EQ 250MG/50ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| LEVAQUIN | LEVOFLOXACIN | INJECTABLE;INJECTION | EQ 500MG/20ML (EQ 25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | INJECTABLE;INJECTION | EQ 500MG/100ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| LEVAQUIN | LEVOFLOXACIN | INJECTABLE;INJECTION | EQ 750MG/30ML (EQ 25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | INJECTABLE;INJECTION | EQ 750MG/150ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA020634 - JANSSEN PHARMS | |||||||
| LEVAQUIN | LEVOFLOXACIN | TABLET;ORAL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| LEVAQUIN | LEVOFLOXACIN | TABLET;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| LEVAQUIN | LEVOFLOXACIN | TABLET;ORAL | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA020606 - J AND J CONSUMER INC | |||||||
| IMODIUM MULTI-SYMPTOM RELIEF | LOPERAMIDE HYDROCHLORIDE; SIMETHICONE | TABLET, CHEWABLE;ORAL | 2MG;125MG | Discontinued | |||
| NDA020603 - KENVUE BRANDS | |||||||
| CHILDREN'S MOTRIN | IBUPROFEN | SUSPENSION/DROPS;ORAL | 40MG/ML | Over-the-counter | |||
| NDA020602 - KENVUE BRANDS | |||||||
| JUNIOR STRENGTH MOTRIN | IBUPROFEN | TABLET;ORAL | 100MG | Over-the-counter | |||
| NDA020601 - KENVUE BRANDS | |||||||
| CHILDREN'S MOTRIN | IBUPROFEN | TABLET, CHEWABLE;ORAL | 50MG | Discontinued | |||
| JUNIOR STRENGTH MOTRIN | IBUPROFEN | TABLET, CHEWABLE;ORAL | 100MG | Discontinued | |||
| NDA020588 - JANSSEN PHARMS | |||||||
| RISPERDAL | RISPERIDONE | SOLUTION;ORAL | 1MG/ML | Prescription | |||
| NDA020516 - KENVUE BRANDS | |||||||
| CHILDREN'S MOTRIN | IBUPROFEN | SUSPENSION;ORAL | 100MG/5ML | Over-the-counter | |||
| NDA020505 - JANSSEN PHARMS | |||||||
| TOPAMAX | TOPIRAMATE | TABLET;ORAL | 100MG | Prescription | |||
| TOPAMAX | TOPIRAMATE | TABLET;ORAL | 200MG | Prescription | |||
| TOPAMAX | TOPIRAMATE | TABLET;ORAL | 50MG | Prescription | |||
| TOPAMAX | TOPIRAMATE | TABLET;ORAL | 400MG | Discontinued | |||
| TOPAMAX | TOPIRAMATE | TABLET;ORAL | 300MG | Discontinued | |||
| TOPAMAX | TOPIRAMATE | TABLET;ORAL | 25MG | Prescription | |||
| NDA020485 - KENVUE BRANDS | |||||||
| VISINE | NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE | SOLUTION/DROPS;OPHTHALMIC | 0.025%;0.3% | Over-the-counter | |||
| NDA020448 - J AND J CONSUMER INC | |||||||
| IMODIUM A-D EZ CHEWS | LOPERAMIDE HYDROCHLORIDE | TABLET, CHEWABLE;ORAL | 2MG | Discontinued | |||
| NDA020398 - JANSSEN PHARMS | |||||||
| PROPULSID | CISAPRIDE MONOHYDRATE | SUSPENSION;ORAL | EQ 1MG BASE/ML | Discontinued | |||
| NDA020346 - J AND J CONSUMER INC | |||||||
| ZYRTEC | CETIRIZINE HYDROCHLORIDE | SOLUTION;ORAL | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA020325 - KENVUE BRANDS | |||||||
| PEPCID AC | FAMOTIDINE | TABLET;ORAL | 20MG | Over-the-counter | |||
| PEPCID AC | FAMOTIDINE | TABLET;ORAL | 10MG | Over-the-counter | |||
| NDA020301 - JANSSEN PHARMS | |||||||
| ORTHO-CEPT | DESOGESTREL; ETHINYL ESTRADIOL | TABLET;ORAL-21 | 0.15MG;0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| ORTHO-CEPT | DESOGESTREL; ETHINYL ESTRADIOL | TABLET;ORAL-28 | 0.15MG;0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA020281 - JANSSEN PHARMS | |||||||
| ULTRAM | TRAMADOL HYDROCHLORIDE | TABLET;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| ULTRAM | TRAMADOL HYDROCHLORIDE | TABLET;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA020272 - JANSSEN PHARMS | |||||||
| RISPERDAL | RISPERIDONE | TABLET;ORAL | 5MG | Discontinued | |||
| RISPERDAL | RISPERIDONE | TABLET;ORAL | 0.25MG | Prescription | |||
| RISPERDAL | RISPERIDONE | TABLET;ORAL | 0.5MG | Prescription | |||
| RISPERDAL | RISPERIDONE | TABLET;ORAL | 2MG | Prescription | |||
| RISPERDAL | RISPERIDONE | TABLET;ORAL | 1MG | Prescription | |||
| RISPERDAL | RISPERIDONE | TABLET;ORAL | 3MG | Prescription | |||
| RISPERDAL | RISPERIDONE | TABLET;ORAL | 4MG | Prescription | |||
| NDA020229 - JANSSEN PHARMS | |||||||
| LEUSTATIN | CLADRIBINE | INJECTABLE;INJECTION | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA020210 - JANSSEN PHARMS | |||||||
| PROPULSID | CISAPRIDE MONOHYDRATE | TABLET;ORAL | EQ 10MG BASE | Discontinued | |||
| PROPULSID | CISAPRIDE MONOHYDRATE | TABLET;ORAL | EQ 20MG BASE | Discontinued | |||
| NDA020193 - JANSSEN PHARMS | |||||||
| ELMIRON | PENTOSAN POLYSULFATE SODIUM | CAPSULE;ORAL | 100MG | Prescription | |||
| NDA020083 - JANSSEN PHARMS | |||||||
| SPORANOX | ITRACONAZOLE | CAPSULE;ORAL | 100MG | Prescription | |||
| NDA020035 - JANSSEN PHARMA | |||||||
| ERGAMISOL | LEVAMISOLE HYDROCHLORIDE | TABLET;ORAL | EQ 50MG BASE | Discontinued | |||
| NDA020021 - KENVUE BRANDS | |||||||
| SUDAFED 24 HOUR | PSEUDOEPHEDRINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 240MG | Over-the-counter | |||
| NDA019964 - JANSSEN PHARMS | |||||||
| TERAZOL 3 | TERCONAZOLE | CREAM;VAGINAL | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA019927 - JANSSEN PHARMS | |||||||
| NIZORAL | KETOCONAZOLE | SHAMPOO;TOPICAL | 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA019899 - KENVUE BRANDS | |||||||
| SINE-AID IB | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | TABLET;ORAL | 200MG;30MG | Over-the-counter | |||
| NDA019872 - KENVUE BRANDS | |||||||
| TYLENOL | ACETAMINOPHEN | TABLET, EXTENDED RELEASE;ORAL | 650MG | Over-the-counter | |||
| TYLENOL | ACETAMINOPHEN | TABLET, EXTENDED RELEASE;ORAL | 650MG | Over-the-counter | |||
| NDA019860 - KENVUE BRANDS | |||||||
| IMODIUM A-D | LOPERAMIDE HYDROCHLORIDE | TABLET;ORAL | 2MG | Over-the-counter | |||
| NDA019835 - KENVUE BRANDS | |||||||
| ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | TABLET;ORAL | 5MG | Discontinued | |||
| ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | TABLET;ORAL | 10MG | Over-the-counter | |||
| ZYRTEC HIVES | CETIRIZINE HYDROCHLORIDE | TABLET;ORAL | 5MG | Discontinued | |||
| ZYRTEC HIVES | CETIRIZINE HYDROCHLORIDE | TABLET;ORAL | 10MG | Discontinued | |||
| NDA019813 - JANSSEN PHARMS | |||||||
| DURAGESIC-100 | FENTANYL | FILM, EXTENDED RELEASE;TRANSDERMAL | 100MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| DURAGESIC-75 | FENTANYL | FILM, EXTENDED RELEASE;TRANSDERMAL | 75MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| DURAGESIC-50 | FENTANYL | FILM, EXTENDED RELEASE;TRANSDERMAL | 50MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| DURAGESIC-25 | FENTANYL | FILM, EXTENDED RELEASE;TRANSDERMAL | 25MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| DURAGESIC-12 | FENTANYL | FILM, EXTENDED RELEASE;TRANSDERMAL | 12.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| DURAGESIC-37 | FENTANYL | FILM, EXTENDED RELEASE;TRANSDERMAL | 37.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA019735 - JANSSEN PHARMS | |||||||
| FLOXIN | OFLOXACIN | TABLET;ORAL | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| FLOXIN | OFLOXACIN | TABLET;ORAL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| FLOXIN | OFLOXACIN | TABLET;ORAL | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA019697 - JANSSEN PHARMS | |||||||
| ORTHO TRI-CYCLEN | ETHINYL ESTRADIOL; NORGESTIMATE | TABLET;ORAL-21 | 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| ORTHO TRI-CYCLEN | ETHINYL ESTRADIOL; NORGESTIMATE | TABLET;ORAL-28 | 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA019653 - JANSSEN PHARMS | |||||||
| ORTHO CYCLEN-21 | ETHINYL ESTRADIOL; NORGESTIMATE | TABLET;ORAL-21 | 0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| ORTHO CYCLEN-28 | ETHINYL ESTRADIOL; NORGESTIMATE | TABLET;ORAL-28 | 0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA019641 - JANSSEN PHARMS | |||||||
| TERAZOL 3 | TERCONAZOLE | SUPPOSITORY;VAGINAL | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA019579 - JANSSEN PHARMS | |||||||
| TERAZOL 7 | TERCONAZOLE | CREAM;VAGINAL | 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA019501 - KENVUE BRANDS | |||||||
| ROGAINE (FOR MEN) | MINOXIDIL | SOLUTION;TOPICAL | 2% | Over-the-counter | |||
| ROGAINE (FOR WOMEN) | MINOXIDIL | SOLUTION;TOPICAL | 2% | Over-the-counter | |||
| NDA019487 - KENVUE BRANDS | |||||||
| IMODIUM A-D | LOPERAMIDE HYDROCHLORIDE | SUSPENSION;ORAL | 1MG/7.5ML | Over-the-counter | |||
| IMODIUM A-D | LOPERAMIDE HYDROCHLORIDE | SOLUTION;ORAL | 1MG/5ML | Over-the-counter | |||
| NDA019407 - KENVUE BRANDS | |||||||
| VISINE L.R. | OXYMETAZOLINE HYDROCHLORIDE | SOLUTION/DROPS;OPHTHALMIC | 0.025% | Over-the-counter | |||
| NDA019084 - JANSSEN PHARMA | |||||||
| NIZORAL | KETOCONAZOLE | CREAM;TOPICAL | 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA019037 - JANSSEN PHARMS | |||||||
| IMODIUM | LOPERAMIDE HYDROCHLORIDE | SOLUTION;ORAL | 1MG/5ML | Discontinued | |||
| NDA019012 - KENVUE BRANDS | |||||||
| MOTRIN IB | IBUPROFEN | TABLET;ORAL | 200MG | Over-the-counter | |||
| NUPRIN | IBUPROFEN | TABLET;ORAL | 200MG | Discontinued | |||
| MOTRIN MIGRAINE PAIN | IBUPROFEN | TABLET;ORAL | 200MG | Discontinued | |||
| NUPRIN | IBUPROFEN | TABLET;ORAL | 200MG | Discontinued | |||
| NDA019002 - JOHNSON AND JOHNSON | |||||||
| VASCOR | BEPRIDIL HYDROCHLORIDE | TABLET;ORAL | 200MG | Discontinued | |||
| VASCOR | BEPRIDIL HYDROCHLORIDE | TABLET;ORAL | 300MG | Discontinued | |||
| VASCOR | BEPRIDIL HYDROCHLORIDE | TABLET;ORAL | 400MG | Discontinued | |||
| NDA018985 - JANSSEN PHARMS | |||||||
| ORTHO-NOVUM 7/7/7-28 | ETHINYL ESTRADIOL; NORETHINDRONE | TABLET;ORAL-28 | 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| ORTHO-NOVUM 7/7/7-21 | ETHINYL ESTRADIOL; NORETHINDRONE | TABLET;ORAL-21 | 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG | Discontinued | |||
| NDA018701 - JANSSEN PHARMS | |||||||
| HALDOL | HALOPERIDOL DECANOATE | INJECTABLE;INJECTION | EQ 50MG BASE/ML | Prescription | |||
| HALDOL | HALOPERIDOL DECANOATE | INJECTABLE;INJECTION | EQ 100MG BASE/ML | Prescription | |||
| NDA018533 - JANSSEN PHARMS | |||||||
| NIZORAL | KETOCONAZOLE | TABLET;ORAL | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA018354 - ORTHO MCNEIL JANSSEN | |||||||
| ORTHO-NOVUM 10/11-21 | ETHINYL ESTRADIOL; NORETHINDRONE | TABLET;ORAL-21 | 0.035MG,0.035MG;0.5MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| ORTHO-NOVUM 10/11-28 | ETHINYL ESTRADIOL; NORETHINDRONE | TABLET;ORAL-28 | 0.035MG,0.035MG;0.5MG,1MG | Discontinued | |||
| NDA018211 - ORTHO MCNEIL JANSSEN | |||||||
| DITROPAN | OXYBUTYNIN CHLORIDE | SYRUP;ORAL | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA018084 - ORTHO MCNEIL JANSSEN | |||||||
| TOLECTIN DS | TOLMETIN SODIUM | CAPSULE;ORAL | EQ 400MG BASE | Discontinued | |||
| NDA018040 - JANSSEN PHARMA | |||||||
| MONISTAT | MICONAZOLE | INJECTABLE;INJECTION | 10MG/ML | Discontinued | |||
| NDA017919 - JANSSEN PHARMS | |||||||
| ORTHO-NOVUM 1/35-28 | ETHINYL ESTRADIOL; NORETHINDRONE | TABLET;ORAL-28 | 0.035MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA017821 - JANSSEN RES AND DEV | |||||||
| FLEXERIL | CYCLOBENZAPRINE HYDROCHLORIDE | TABLET;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| FLEXERIL | CYCLOBENZAPRINE HYDROCHLORIDE | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA017756 - J AND J CONSUMER INC | |||||||
| TYLENOL | ACETAMINOPHEN | SUPPOSITORY;RECTAL | 120MG | Discontinued | |||
| TYLENOL | ACETAMINOPHEN | SUPPOSITORY;RECTAL | 650MG | Discontinued | |||
| NDA017735 - JANSSEN PHARMS | |||||||
| MODICON 28 | ETHINYL ESTRADIOL; NORETHINDRONE | TABLET;ORAL-28 | 0.035MG;0.5MG | Discontinued | |||
| NDA017694 - J AND J CONSUMER INC | |||||||
| IMODIUM | LOPERAMIDE HYDROCHLORIDE | CAPSULE;ORAL | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA017690 - J AND J CONSUMER INC | |||||||
| IMODIUM | LOPERAMIDE HYDROCHLORIDE | CAPSULE;ORAL | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA017628 - ORTHO MCNEIL JANSSEN | |||||||
| TOLECTIN | TOLMETIN SODIUM | TABLET;ORAL | EQ 200MG BASE | Discontinued | |||
| TOLECTIN 600 | TOLMETIN SODIUM | TABLET;ORAL | EQ 600MG BASE | Discontinued | |||
| NDA017577 - JANSSEN PHARMS | |||||||
| DITROPAN | OXYBUTYNIN CHLORIDE | TABLET;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA017481 - JANSSEN PHARMS | |||||||
| VERMOX | MEBENDAZOLE | TABLET, CHEWABLE;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA016954 - JANSSEN PHARMS | |||||||
| MICRONOR | NORETHINDRONE | TABLET;ORAL-28 | 0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA016769 - ORTHO MCNEIL JANSSEN | |||||||
| URISPAS | FLAVOXATE HYDROCHLORIDE | TABLET;ORAL | 100MG | Discontinued | |||
| NDA016709 - ORTHO MCNEIL JANSSEN | |||||||
| ORTHO-NOVUM 1/50 28 | MESTRANOL; NORETHINDRONE | TABLET;ORAL-28 | 0.05MG;1MG | Discontinued | |||
| NDA015923 - JANSSEN PHARMS | |||||||
| HALDOL | HALOPERIDOL LACTATE | INJECTABLE;INJECTION | EQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA011529 - JANSSEN R AND D | |||||||
| PARAFON FORTE DSC | CHLORZOXAZONE | TABLET;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||