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AstraZeneca PLC

AstraZeneca PLC (AZN)

FDA Applications

Note: This list only includes applications that have been responded to by the FDA.

ApplicationProduct NameActive IngredientFormStrengthStatus
BLA761328 - ASTRAZENECA AB
BEYFORTUSNIRSEVIMAB-ALIPINJECTABLE;INJECTION50MGPrescription
BEYFORTUSNIRSEVIMAB-ALIPINJECTABLE;INJECTION100MGPrescription
BLA761289 - ASTRAZENECA AB
IMJUDOTREMELIMUMAB-ACTL INJECTABLE;INTRAVENOUS25MG/1.25ML(20MG/ML)Prescription
IMJUDOTREMELIMUMAB-ACTL INJECTABLE;INTRAVENOUS300MG/15ML(20MG/ML)Prescription
BLA761270 - ASTRAZENECA AB
IMJUDOTREMELIMUMAB-ACTLINJECTABLE;INTRAVENOUS25MG/1.25ML(20MG/ML)Prescription
IMJUDOTREMELIMUMAB-ACTLINJECTABLE;INTRAVENOUS300MG/15ML(20MG/ML)Prescription
BLA761224 - ASTRAZENECA AB
TEZSPIRETEZEPELUMAB-EKKOSOLUTION;SUBCUTANEOUS210MG/1.91ML(110MG/ML)Prescription
BLA761123 - ASTRAZENECA AB
SAPHNELOANIFROLUMAB-FNIAINJECTABLE;INJECTION300MG/2ML(150MG/ML)Prescription
BLA761070 - ASTRAZENECA AB
FASENRABENRALIZUMABINJECTABLE;INJECTION30MG/MLPrescription
BLA761069 - ASTRAZENECA UK LTD
IMFINZIDURVALUMABINJECTABLE;INJECTION50MG/MLPrescription
NDA218197 - ASTRAZENECA
TRUQAPCAPIVASERTIBTABLET;ORAL160MGPrescription
TRUQAPCAPIVASERTIBTABLET;ORAL200MGPrescription
NDA217388 - ASTRAZENECA AB
WAINUA (AUTOINJECTOR)EPLONTERSEN SODIUMSOLUTION;SUBCUTANEOUSEQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML)Prescription
NDA216579 - ASTRAZENECA
SYMBICORT AEROSPHEREBUDESONIDE; FORMOTEROL FUMARATEAEROSOL, METERED;INHALATION0.16MG/INH;0.0048MG/INHPrescription
NDA216387 - ASTRAZENECA
CALQUENCEACALABRUTINIB MALEATETABLET;ORALEQ 100MG BASEPrescription
NDA214070 - ASTRAZENECA
AIRSUPRAALBUTEROL SULFATE; BUDESONIDEAEROSOL, METERED;INHALATIONEQ 0.09MG BASE/INH;0.08MG/INHPrescription
NDA213756 - ASTRAZENECA
KOSELUGOSELUMETINIB SULFATECAPSULE;ORALEQ 25MG BASEPrescription
KOSELUGOSELUMETINIB SULFATECAPSULE;ORALEQ 10MG BASEPrescription
NDA212122 - ASTRAZENECA AB
BREZTRI AEROSPHEREBUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATEAEROSOL, METERED;INHALATION0.16MG/INH;0.0048MG/INH;0.009MG/INHPrescription
NDA210874 - ASTRAZENECA AB
QTERNMET XRDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL2.5MG;1GM;EQ 2.5MG BASEDiscontinued
QTERNMET XRDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL5MG;1GM;EQ 2.5MG BASEDiscontinued
QTERNMET XRDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL5MG;1GM;EQ 5MG BASEDiscontinued
QTERNMET XRDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL10MG;1GM;EQ 5MG BASEDiscontinued
NDA210259 - ASTRAZENECA
CALQUENCEACALABRUTINIBCAPSULE;ORAL100MGPrescription
NDA209210 - ASTRAZENECA AB
BYDUREON BCISEEXENATIDE SYNTHETICSUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS2MG/0.85ML (2MG/0.85ML)Prescription
NDA209091 - ASTRAZENECA AB
QTERNDAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDETABLET;ORAL5MG;EQ 5MG BASEPrescription
QTERNDAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDETABLET;ORAL10MG;EQ 5MG BASEPrescription
NDA208558 - ASTRAZENECA
LYNPARZAOLAPARIBTABLET;ORAL150MGPrescription
LYNPARZAOLAPARIBTABLET;ORAL100MGPrescription
NDA208294 - ASTRAZENECA
BEVESPI AEROSPHEREFORMOTEROL FUMARATE; GLYCOPYRROLATEAEROSOL, METERED;INHALATION0.0048MG/INH;0.0090MG/INHPrescription
NDA208065 - ASTRAZENECA
TAGRISSOOSIMERTINIB MESYLATETABLET;ORALEQ 80MG BASEPrescription
TAGRISSOOSIMERTINIB MESYLATETABLET;ORALEQ 40MG BASEPrescription
NDA207920 - ASTRAZENECA LP
NEXIUM 24HRESOMEPRAZOLE MAGNESIUMTABLET, DELAYED RELEASE;ORALEQ 20MG BASEOver-the-counter
NDA207078 - ASTRAZENECA
LOKELMASODIUM ZIRCONIUM CYCLOSILICATEFOR SUSPENSION;ORAL5GM/PACKETPrescription
LOKELMASODIUM ZIRCONIUM CYCLOSILICATEFOR SUSPENSION;ORAL10GM/PACKETPrescription
NDA206995 - ASTRAZENECA
IRESSAGEFITINIBTABLET;ORAL250MGPrescription
NDA206162 - ASTRAZENECA
LYNPARZAOLAPARIBCAPSULE;ORAL50MGDiscontinued
NDA205649 - ASTRAZENECA AB
XIGDUO XRDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL5MG;500MGPrescription
XIGDUO XRDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL5MG;1GMPrescription
XIGDUO XRDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL10MG;500MGPrescription
XIGDUO XRDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL10MG;1GMPrescription
XIGDUO XRDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL2.5MG;1GMPrescription
NDA205060 - ASTRAZENECA
EPANOVAOMEGA-3-CARBOXYLIC ACIDSCAPSULE;ORAL1GM CONTAINS AT LEAST 850MG OF POLYUNSATURATED FATTY ACIDSDiscontinued
NDA204655 - ASTRAZENECA LP
NEXIUM 24HRESOMEPRAZOLE MAGNESIUMCAPSULE, DELAYED RELEASE;ORALEQ 20MG BASEOver-the-counter
NDA202293 - ASTRAZENECA AB
FARXIGADAPAGLIFLOZINTABLET;ORAL5MGPrescription
FARXIGADAPAGLIFLOZINTABLET;ORAL10MGPrescription
NDA200678 - ASTRAZENECA AB
KOMBIGLYZE XRMETFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL500MG;EQ 5MG BASEDiscontinued
KOMBIGLYZE XRMETFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL1GM;EQ 5MG BASEDiscontinued
KOMBIGLYZE XRMETFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL1GM;EQ 2.5MG BASEDiscontinued
ANDA089618 - ASTRAZENECA
ISOETHARINE HYDROCHLORIDEISOETHARINE HYDROCHLORIDESOLUTION;INHALATION0.25%Discontinued
ANDA089617 - ASTRAZENECA
ISOETHARINE HYDROCHLORIDEISOETHARINE HYDROCHLORIDESOLUTION;INHALATION0.2%Discontinued
ANDA089616 - ASTRAZENECA
ISOETHARINE HYDROCHLORIDEISOETHARINE HYDROCHLORIDESOLUTION;INHALATION0.167%Discontinued
ANDA089615 - ASTRAZENECA
ISOETHARINE HYDROCHLORIDEISOETHARINE HYDROCHLORIDESOLUTION;INHALATION0.125%Discontinued
ANDA089614 - ASTRAZENECA
ISOETHARINE HYDROCHLORIDEISOETHARINE HYDROCHLORIDESOLUTION;INHALATION0.062%Discontinued
ANDA088472 - ASTRAZENECA
ISOETHARINE HYDROCHLORIDEISOETHARINE HYDROCHLORIDESOLUTION;INHALATION0.25%Discontinued
ANDA088471 - ASTRAZENECA
ISOETHARINE HYDROCHLORIDEISOETHARINE HYDROCHLORIDESOLUTION;INHALATION0.2%Discontinued
ANDA088470 - ASTRAZENECA
ISOETHARINE HYDROCHLORIDEISOETHARINE HYDROCHLORIDESOLUTION;INHALATION0.167%Discontinued
ANDA088125 - ASTRAZENECA
SORBITRATEISOSORBIDE DINITRATETABLET;ORAL40MGDiscontinued
ANDA088124 - ASTRAZENECA
SORBITRATEISOSORBIDE DINITRATETABLET;ORAL30MGDiscontinued
ANDA087938 - ASTRAZENECA
ISOETHARINE HYDROCHLORIDEISOETHARINE HYDROCHLORIDESOLUTION;INHALATION0.125%Discontinued
ANDA087937 - ASTRAZENECA
ISOETHARINE HYDROCHLORIDEISOETHARINE HYDROCHLORIDESOLUTION;INHALATION0.062%Discontinued
ANDA086405 - ASTRAZENECA
SORBITRATEISOSORBIDE DINITRATETABLET;ORAL20MGDiscontinued
ANDA083080 - ASTRAZENECA
AQUASOL AVITAMIN ACAPSULE;ORAL25,000USP UNITSDiscontinued
AQUASOL AVITAMIN ACAPSULE;ORAL50,000USP UNITSDiscontinued
ANDA072081 - ASTRAZENECA
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEINJECTABLE;INJECTION0.02MG/MLDiscontinued
ANDA072028 - ASTRAZENECA
FENTANYL CITRATE AND DROPERIDOLDROPERIDOL; FENTANYL CITRATEINJECTABLE;INJECTION2.5MG/ML;EQ 0.05MG BASE/MLDiscontinued
ANDA072027 - ASTRAZENECA
FENTANYL CITRATE AND DROPERIDOLDROPERIDOL; FENTANYL CITRATEINJECTABLE;INJECTION2.5MG/ML;EQ 0.05MG BASE/MLDiscontinued
ANDA072026 - ASTRAZENECA
FENTANYL CITRATE AND DROPERIDOLDROPERIDOL; FENTANYL CITRATEINJECTABLE;INJECTION2.5MG/ML;EQ 0.05MG BASE/MLDiscontinued
ANDA072018 - ASTRAZENECA
DROPERIDOLDROPERIDOLINJECTABLE;INJECTION2.5MG/MLDiscontinued
ANDA071275 - ASTRAZENECA
METAPROTERENOL SULFATEMETAPROTERENOL SULFATESOLUTION;INHALATION0.4%Discontinued
ANDA071153 - ASTRAZENECA
BRETYLIUM TOSYLATEBRETYLIUM TOSYLATEINJECTABLE;INJECTION50MG/MLDiscontinued
ANDA071152 - ASTRAZENECA
BRETYLIUM TOSYLATEBRETYLIUM TOSYLATEINJECTABLE;INJECTION50MG/MLDiscontinued
ANDA071151 - ASTRAZENECA
BRETYLIUM TOSYLATEBRETYLIUM TOSYLATEINJECTABLE;INJECTION50MG/MLDiscontinued
ANDA071018 - ASTRAZENECA
METAPROTERENOL SULFATEMETAPROTERENOL SULFATESOLUTION;INHALATION0.6%Discontinued
ANDA070014 - ASTRAZENECA
FUROSEMIDEFUROSEMIDEINJECTABLE;INJECTION10MG/MLDiscontinued
NDA022522 - ASTRAZENECA
DALIRESPROFLUMILASTTABLET;ORAL250MCGPrescription
DALIRESPROFLUMILASTTABLET;ORAL500MCGPrescription
NDA022433 - ASTRAZENECA
BRILINTATICAGRELORTABLET;ORAL60MGPrescription
BRILINTATICAGRELORTABLET;ORAL90MGPrescription
NDA022350 - ASTRAZENECA AB
ONGLYZASAXAGLIPTIN HYDROCHLORIDETABLET;ORALEQ 2.5MG BASEDiscontinued
ONGLYZASAXAGLIPTIN HYDROCHLORIDETABLET;ORALEQ 5MG BASEDiscontinued
NDA022310 - ASTRAZENECA
CASODEXBICALUTAMIDETABLET; ORAL50MGPrescription
NDA022214 - ASTRAZENECA
ARIMIDEXANASTROZOLETABLET; ORAL1MGPrescription
NDA022200 - ASTRAZENECA AB
BYDUREONEXENATIDE SYNTHETICFOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS2MG/VIALDiscontinued
BYDUREON PENEXENATIDE SYNTHETICFOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS2MGDiscontinued
NDA022172 - ASTRAZENECA
SEROQUEL XRQUETIAPINE FUMARATETABLET, EXTENDED RELEASE; ORAL50MGPrescription
SEROQUEL XRQUETIAPINE FUMARATETABLET, EXTENDED RELEASE; ORAL200MGPrescription
SEROQUEL XRQUETIAPINE FUMARATETABLET, EXTENDED RELEASE; ORAL300MGPrescription
SEROQUEL XRQUETIAPINE FUMARATETABLET, EXTENDED RELEASE; ORAL400MGPrescription
NDA022101 - ASTRAZENECA
NEXIUMESOMEPRAZOLE MAGNESIUMFOR SUSPENSION, DELAYED RELEASE;ORALEQ 10MG BASE/PACKETPrescription
NDA022047 - ASTRAZENECA
SEROQUEL XRQUETIAPINE FUMARATETABLET, EXTENDED RELEASE;ORALEQ 50MG BASEPrescription
SEROQUEL XRQUETIAPINE FUMARATETABLET, EXTENDED RELEASE;ORALEQ 200MG BASEPrescription
SEROQUEL XRQUETIAPINE FUMARATETABLET, EXTENDED RELEASE;ORALEQ 300MG BASEPrescription
SEROQUEL XRQUETIAPINE FUMARATETABLET, EXTENDED RELEASE;ORALEQ 400MG BASEPrescription
SEROQUEL XRQUETIAPINE FUMARATETABLET, EXTENDED RELEASE;ORALEQ 150MG BASEPrescription
NDA021957 - ASTRAZENECA
NEXIUMESOMEPRAZOLE MAGNESIUMFOR SUSPENSION, DELAYED RELEASE;ORALEQ 2.5MG BASE/PACKETPrescription
NEXIUMESOMEPRAZOLE MAGNESIUMFOR SUSPENSION, DELAYED RELEASE;ORALEQ 5MG BASE/PACKETPrescription
NEXIUMESOMEPRAZOLE MAGNESIUMFOR SUSPENSION, DELAYED RELEASE;ORALEQ 20MG BASE/PACKETPrescription
NEXIUMESOMEPRAZOLE MAGNESIUMFOR SUSPENSION, DELAYED RELEASE;ORALEQ 40MG BASE/PACKETPrescription
NDA021929 - ASTRAZENECA
SYMBICORTBUDESONIDE; FORMOTEROL FUMARATE DIHYDRATEAEROSOL, METERED;INHALATION0.16MG/INH;0.0045MG/INHPrescription
SYMBICORTBUDESONIDE; FORMOTEROL FUMARATE DIHYDRATEAEROSOL, METERED;INHALATION0.08MG/INH;0.0045MG/INHPrescription
NDA021773 - ASTRAZENECA AB
BYETTAEXENATIDE SYNTHETICINJECTABLE;SUBCUTANEOUS300MCG/1.2ML (250MCG/ML)Prescription
BYETTAEXENATIDE SYNTHETICINJECTABLE;SUBCUTANEOUS600MCG/2.4ML (250MCG/ML)Prescription
NDA021689 - ASTRAZENECA
NEXIUM IVESOMEPRAZOLE SODIUMINJECTABLE;INTRAVENOUSEQ 40MG BASE/VIALDiscontinued
NEXIUM IVESOMEPRAZOLE SODIUMINJECTABLE;INTRAVENOUSEQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA021399 - ASTRAZENECA
IRESSAGEFITINIBTABLET;ORAL250MGDiscontinued
NDA021344 - ASTRAZENECA
FASLODEXFULVESTRANTSOLUTION;INTRAMUSCULAR125MG/2.5ML (50MG/ML)Discontinued
FASLODEXFULVESTRANTSOLUTION;INTRAMUSCULAR250MG/5ML (50MG/ML)Prescription
NDA021332 - ASTRAZENECA AB
SYMLINPRAMLINTIDE ACETATEINJECTABLE;SUBCUTANEOUSEQ 3MG BASE/5ML (EQ 600MCG BASE/ML)Discontinued
SYMLINPRAMLINTIDE ACETATEINJECTABLE;SUBCUTANEOUSEQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)Prescription
SYMLINPRAMLINTIDE ACETATEINJECTABLE;SUBCUTANEOUSEQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)Prescription
NDA021311 - ASTRAZENECA PHARMS
NDA021231 - ASTRAZENECA
ZOMIG-ZMTZOLMITRIPTANTABLET, ORALLY DISINTEGRATING;ORAL5MGDiscontinued
ZOMIG-ZMTZOLMITRIPTANTABLET, ORALLY DISINTEGRATING;ORAL2.5MGDiscontinued
NDA021229 - ASTRAZENECA
PRILOSEC OTCOMEPRAZOLE MAGNESIUMTABLET, DELAYED RELEASE;ORALEQ 20MG BASEOver-the-counter
NDA021153 - ASTRAZENECA
NEXIUMESOMEPRAZOLE MAGNESIUMCAPSULE, DELAYED REL PELLETS;ORALEQ 40MG BASEPrescription
NEXIUMESOMEPRAZOLE MAGNESIUMCAPSULE, DELAYED REL PELLETS;ORALEQ 20MG BASEPrescription
NDA020962 - ASTRAZENECA
EMLALIDOCAINE; PRILOCAINEDISC;TOPICAL2.5%;2.5%Discontinued
NDA020929 - ASTRAZENECA
PULMICORT RESPULESBUDESONIDESUSPENSION;INHALATION1MG/2MLPrescription
PULMICORT RESPULESBUDESONIDESUSPENSION;INHALATION0.25MG/2MLPrescription
PULMICORT RESPULESBUDESONIDESUSPENSION;INHALATION0.5MG/2MLPrescription
NDA020668 - ASTRAZENECA
LEXXELENALAPRIL MALEATE; FELODIPINETABLET, EXTENDED RELEASE;ORAL5MG;2.5MGDiscontinued
LEXXELENALAPRIL MALEATE; FELODIPINETABLET, EXTENDED RELEASE;ORAL5MG;5MGDiscontinued
NDA020639 - ASTRAZENECA
SEROQUELQUETIAPINE FUMARATETABLET;ORALEQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
SEROQUELQUETIAPINE FUMARATETABLET;ORALEQ 300MG BASEPrescription
SEROQUELQUETIAPINE FUMARATETABLET;ORALEQ 400MG BASEPrescription
SEROQUELQUETIAPINE FUMARATETABLET;ORALEQ 200MG BASEPrescription
SEROQUELQUETIAPINE FUMARATETABLET;ORALEQ 25MG BASEPrescription
SEROQUELQUETIAPINE FUMARATETABLET;ORALEQ 100MG BASEPrescription
SEROQUELQUETIAPINE FUMARATETABLET;ORALEQ 50MG BASEPrescription
NDA020441 - ASTRAZENECA
PULMICORTBUDESONIDEPOWDER, METERED;INHALATION0.32MG/INHDiscontinued
PULMICORTBUDESONIDEPOWDER, METERED;INHALATION0.16MG/INHDiscontinued
NDA020233 - ASTRAZENECA
RHINOCORTBUDESONIDEAEROSOL, METERED;NASAL0.032MG/INHDiscontinued
NDA019834 - ASTRAZENECA
PLENDILFELODIPINETABLET, EXTENDED RELEASE;ORAL5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
PLENDILFELODIPINETABLET, EXTENDED RELEASE;ORAL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
PLENDILFELODIPINETABLET, EXTENDED RELEASE;ORAL2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA019810 - ASTRAZENECA
PRILOSECOMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
PRILOSECOMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
PRILOSECOMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA019082 - ASTRAZENECA
DALGANDEZOCINEINJECTABLE;INJECTION10MG/MLDiscontinued
DALGANDEZOCINEINJECTABLE;INJECTION15MG/MLDiscontinued
DALGANDEZOCINEINJECTABLE;INJECTION5MG/MLDiscontinued
NDA019058 - ASTRAZENECA
TENORMINATENOLOLINJECTABLE;INJECTION0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA018580 - ASTRAZENECA
YUTOPARRITODRINE HYDROCHLORIDEINJECTABLE;INJECTION10MG/MLDiscontinued
YUTOPARRITODRINE HYDROCHLORIDEINJECTABLE;INJECTION15MG/MLDiscontinued
NDA018555 - ASTRAZENECA
YUTOPARRITODRINE HYDROCHLORIDETABLET;ORAL10MGDiscontinued
NDA018257 - ASTRAZENECA
TONOCARDTOCAINIDE HYDROCHLORIDETABLET;ORAL400MGDiscontinued
TONOCARDTOCAINIDE HYDROCHLORIDETABLET;ORAL600MGDiscontinued
NDA017970 - ASTRAZENECA
NOLVADEXTAMOXIFEN CITRATETABLET;ORALEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NOLVADEXTAMOXIFEN CITRATETABLET;ORALEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA017751 - ASTRAZENECA
DURANESTETIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
DURANESTEPINEPHRINE; ETIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION0.005MG/ML;0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
DURANESTETIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
DURANESTEPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION0.005MG/ML;1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
DURANESTEPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION0.005MG/ML;1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA016776 - ASTRAZENECA
SORBITRATEISOSORBIDE DINITRATETABLET, CHEWABLE;ORAL5MGDiscontinued
SORBITRATEISOSORBIDE DINITRATETABLET, CHEWABLE;ORAL10MGDiscontinued
NDA016192 - ASTRAZENECA
SORBITRATEISOSORBIDE DINITRATETABLET;ORAL5MGDiscontinued
SORBITRATEISOSORBIDE DINITRATETABLET;ORAL10MGDiscontinued
NDA016191 - ASTRAZENECA
SORBITRATEISOSORBIDE DINITRATETABLET;SUBLINGUAL5MGDiscontinued
SORBITRATEISOSORBIDE DINITRATETABLET;SUBLINGUAL2.5MGDiscontinued
NDA014763 - ASTRAZENECA
CITANESTPRILOCAINE HYDROCHLORIDEINJECTABLE;INJECTION3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
CITANESTPRILOCAINE HYDROCHLORIDEINJECTABLE;INJECTION1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
CITANESTPRILOCAINE HYDROCHLORIDEINJECTABLE;INJECTION2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
CITANEST PLAINPRILOCAINE HYDROCHLORIDEINJECTABLE;INJECTION4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
CITANEST FORTEEPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDEINJECTABLE;INJECTION0.005MG/ML;4%Discontinued
NDA014394 - ASTRAZENECA
XYLOCAINELIDOCAINEAEROSOL;ORAL10%Discontinued
NDA014127 - ASTRAZENECA
XYLOCAINELIDOCAINESOLUTION;TOPICAL5%Discontinued
NDA013077 - ASTRAZENECA
XYLOCAINELIDOCAINESUPPOSITORY;RECTAL100MGDiscontinued
NDA012704 - ASTRAZENECA
ELAVILAMITRIPTYLINE HYDROCHLORIDEINJECTABLE;INJECTION10MG/MLDiscontinued
NDA012703 - ASTRAZENECA
ELAVILAMITRIPTYLINE HYDROCHLORIDETABLET;ORAL75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
ELAVILAMITRIPTYLINE HYDROCHLORIDETABLET;ORAL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
ELAVILAMITRIPTYLINE HYDROCHLORIDETABLET;ORAL25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
ELAVILAMITRIPTYLINE HYDROCHLORIDETABLET;ORAL50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
ELAVILAMITRIPTYLINE HYDROCHLORIDETABLET;ORAL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
ELAVILAMITRIPTYLINE HYDROCHLORIDETABLET;ORAL150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA010496 - ASTRAZENECA
XYLOCAINE 5% W/ GLUCOSE 7.5%LIDOCAINE HYDROCHLORIDEINJECTABLE;SPINAL5%Discontinued
NDA010418 - ASTRAZENECA
XYLOCAINELIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION1%Discontinued
XYLOCAINE W/ EPINEPHRINEEPINEPHRINE; LIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION0.005MG/ML;1%Discontinued
XYLOCAINELIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION2%Discontinued
XYLOCAINE W/ EPINEPHRINEEPINEPHRINE; LIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION0.005MG/ML;2%Discontinued
XYLOCAINELIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION1.5%Discontinued
XYLOCAINE W/ EPINEPHRINEEPINEPHRINE; LIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION0.005MG/ML;1.5%Discontinued
NDA009925 - ASTRAZENECA
DYCLONEDYCLONINE HYDROCHLORIDESOLUTION;TOPICAL1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
DYCLONEDYCLONINE HYDROCHLORIDESOLUTION;TOPICAL0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA008048 - ASTRAZENECA
XYLOCAINELIDOCAINEOINTMENT;TOPICAL5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued