Takeda Pharmaceutical Company Limited (TAK)
FDA Applications
Note: This list only includes applications that have been responded to by the FDA.
| Application | Product Name | Active Ingredient | Form | Strength | Status | ||
|---|---|---|---|---|---|---|---|
| BLA761359 - TAKEDA PHARMS USA | |||||||
| ENTYVIO | VEDOLIZUMAB | INJECTABLE;INTRAVENOUS | 300MG | Prescription | |||
| ENTYVIO | VEDOLIZUMAB | INJECTABLE;SUBCUTANEOUS | 108MG/0.68ML | Prescription | |||
| BLA761133 - TAKEDA PHARMS USA | |||||||
| ENTYVIO | VEDOLIZUMAB | INJECTABLE;INTRAVENOUS | 300MG | Prescription | |||
| ENTYVIO | VEDOLIZUMAB | INJECTABLE;INJECTION | 108MG/0.68ML | Prescription | |||
| NDA217564 - TAKEDA PHARMS USA | |||||||
| FRUZAQLA | FRUQUINTINIB | CAPSULE;ORAL | 1MG | Prescription | |||
| FRUZAQLA | FRUQUINTINIB | CAPSULE;ORAL | 5MG | Prescription | |||
| NDA215596 - TAKEDA PHARMS USA | |||||||
| LIVTENCITY | MARIBAVIR | TABLET;ORAL | 200MG | Prescription | |||
| NDA215310 - TAKEDA PHARMS USA | |||||||
| EXKIVITY | MOBOCERTINIB SUCCINATE | CAPSULE;ORAL | EQ 40MG BASE | Discontinued | |||
| NDA213976 - TAKEDA PHARMS USA | |||||||
| EOHILIA | BUDESONIDE | SUSPENSION;ORAL | 2MG/10ML | Prescription | |||
| NDA210166 - TAKEDA PHARMS USA | |||||||
| MOTEGRITY | PRUCALOPRIDE SUCCINATE | TABLET;ORAL | EQ 1MG BASE | Prescription | |||
| MOTEGRITY | PRUCALOPRIDE SUCCINATE | TABLET;ORAL | EQ 2MG BASE | Prescription | |||
| NDA208772 - TAKEDA PHARMS USA | |||||||
| ALUNBRIG | BRIGATINIB | TABLET;ORAL | 180MG | Prescription | |||
| ALUNBRIG | BRIGATINIB | TABLET;ORAL | 90MG | Prescription | |||
| ALUNBRIG | BRIGATINIB | TABLET;ORAL | 30MG | Prescription | |||
| NDA208510 - TAKEDA PHARMS USA | |||||||
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | TABLET, CHEWABLE;ORAL | 10MG | Prescription | |||
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | TABLET, CHEWABLE;ORAL | 20MG | Prescription | |||
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | TABLET, CHEWABLE;ORAL | 30MG | Prescription | |||
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | TABLET, CHEWABLE;ORAL | 50MG | Prescription | |||
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | TABLET, CHEWABLE;ORAL | 60MG | Prescription | |||
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | TABLET, CHEWABLE;ORAL | 40MG | Prescription | |||
| NDA208462 - TAKEDA PHARMS USA | |||||||
| NINLARO | IXAZOMIB CITRATE | CAPSULE;ORAL | EQ 3MG BASE | Prescription | |||
| NINLARO | IXAZOMIB CITRATE | CAPSULE;ORAL | EQ 4MG BASE | Prescription | |||
| NINLARO | IXAZOMIB CITRATE | CAPSULE;ORAL | EQ 2.3MG BASE | Prescription | |||
| NDA208056 - TAKEDA PHARMS USA | |||||||
| DEXILANT SOLUTAB | DEXLANSOPRAZOLE | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 30MG | Discontinued | |||
| NDA204734 - TAKEDA PHARMS USA | |||||||
| FOSRENOL | LANTHANUM CARBONATE | POWDER;ORAL | EQ 750MG BASE | Prescription | |||
| FOSRENOL | LANTHANUM CARBONATE | POWDER;ORAL | EQ 1GM BASE | Prescription | |||
| NDA204447 - TAKEDA PHARMS USA | |||||||
| TRINTELLIX | VORTIOXETINE HYDROBROMIDE | TABLET;ORAL | EQ 5MG BASE | Prescription | |||
| TRINTELLIX | VORTIOXETINE HYDROBROMIDE | TABLET;ORAL | EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| TRINTELLIX | VORTIOXETINE HYDROBROMIDE | TABLET;ORAL | EQ 20MG BASE | Prescription | |||
| TRINTELLIX | VORTIOXETINE HYDROBROMIDE | TABLET;ORAL | EQ 10MG BASE | Prescription | |||
| NDA203469 - TAKEDA PHARMS USA | |||||||
| ICLUSIG | PONATINIB HYDROCHLORIDE | TABLET;ORAL | EQ 15MG BASE | Prescription | |||
| ICLUSIG | PONATINIB HYDROCHLORIDE | TABLET;ORAL | EQ 45MG BASE | Prescription | |||
| ICLUSIG | PONATINIB HYDROCHLORIDE | TABLET;ORAL | EQ 10MG BASE | Prescription | |||
| ICLUSIG | PONATINIB HYDROCHLORIDE | TABLET;ORAL | EQ 30MG BASE | Prescription | |||
| NDA203441 - TAKEDA PHARMS USA | |||||||
| GATTEX KIT | TEDUGLUTIDE | POWDER;SUBCUTANEOUS | 5MG/VIAL | Prescription | |||
| NDA203414 - TAKEDA PHARMS USA | |||||||
| KAZANO | ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE | TABLET;ORAL | EQ 12.5MG BASE;500MG | Prescription | |||
| KAZANO | ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE | TABLET;ORAL | EQ 12.5MG BASE;1GM | Prescription | |||
| NDA202799 - TAKEDA PHARMS USA | |||||||
| OMONTYS PRESERVATIVE FREE | PEGINESATIDE ACETATE | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | EQ 1MG BASE/0.5ML (EQ 1MG BASE/0.5ML) | Discontinued | |||
| OMONTYS PRESERVATIVE FREE | PEGINESATIDE ACETATE | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | EQ 2MG BASE/0.5ML (EQ 2MG BASE/0.5ML) | Discontinued | |||
| OMONTYS PRESERVATIVE FREE | PEGINESATIDE ACETATE | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) | Discontinued | |||
| OMONTYS PRESERVATIVE FREE | PEGINESATIDE ACETATE | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | EQ 4MG BASE/0.5ML (EQ 4MG BASE/0.5ML) | Discontinued | |||
| OMONTYS PRESERVATIVE FREE | PEGINESATIDE ACETATE | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | EQ 5MG BASE/0.5ML (EQ 5MG BASE/0.5ML) | Discontinued | |||
| OMONTYS PRESERVATIVE FREE | PEGINESATIDE ACETATE | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | EQ 6MG BASE/0.5ML (EQ 6MG BASE/0.5ML) | Discontinued | |||
| OMONTYS | PEGINESATIDE ACETATE | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | EQ 10MG BASE/ML (EQ 10MG BASE/ML) | Discontinued | |||
| OMONTYS | PEGINESATIDE ACETATE | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | EQ 20MG BASE/2ML (EQ 10MG BASE/ML) | Discontinued | |||
| BLA125476 - TAKEDA PHARMS USA | |||||||
| ENTYVIO | VEDOLIZUMAB | INJECTABLE;INJECTION | 300MG | Prescription | |||
| NDA050757 - TAKEDA PHARMS USA | |||||||
| PREVPAC (COPACKAGED) | AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL | 500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA050601 - TAKEDA | |||||||
| CERADON | CEFOTIAM HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | Discontinued | |||
| NDA022426 - TAKEDA PHARMS USA | |||||||
| OSENI | ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE | TABLET;ORAL | EQ 25MG BASE;EQ 15MG BASE | Prescription | |||
| OSENI | ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE | TABLET;ORAL | EQ 25MG BASE;EQ 30MG BASE | Prescription | |||
| OSENI | ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE | TABLET;ORAL | EQ 25MG BASE;EQ 45MG BASE | Prescription | |||
| OSENI | ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE | TABLET;ORAL | EQ 12.5MG BASE;EQ 30MG BASE | Prescription | |||
| OSENI | ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE | TABLET;ORAL | EQ 12.5MG BASE;EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| OSENI | ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE | TABLET;ORAL | EQ 12.5MG BASE;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA022352 - TAKEDA PHARMS USA | |||||||
| COLCRYS | COLCHICINE | TABLET;ORAL | 0.6MG | Discontinued | |||
| NDA022287 - TAKEDA PHARMS USA | |||||||
| DEXILANT | DEXLANSOPRAZOLE | CAPSULE, DELAYED RELEASE;ORAL | 60MG | Prescription | |||
| DEXILANT | DEXLANSOPRAZOLE | CAPSULE, DELAYED RELEASE;ORAL | 30MG | Prescription | |||
| NDA022271 - TAKEDA PHARMS USA | |||||||
| NESINA | ALOGLIPTIN BENZOATE | TABLET;ORAL | EQ 6.25MG BASE | Prescription | |||
| NESINA | ALOGLIPTIN BENZOATE | TABLET;ORAL | EQ 12.5MG BASE | Prescription | |||
| NESINA | ALOGLIPTIN BENZOATE | TABLET;ORAL | EQ 25MG BASE | Prescription | |||
| NDA022150 - TAKEDA PHARMS USA | |||||||
| FIRAZYR | ICATIBANT ACETATE | INJECTABLE;SUBCUTANEOUS | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | Prescription | |||
| NDA022063 - TAKEDA PHARMS USA | |||||||
| MYDAYIS | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 3.125MG;3.125MG;3.125MG;3.125MG | Prescription | |||
| MYDAYIS | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 6.25MG;6.25MG;6.25MG;6.25MG | Prescription | |||
| MYDAYIS | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 9.375MG;9.375MG;9.375MG;9.375MG | Prescription | |||
| MYDAYIS | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 12.5MG;12.5MG;12.5MG;12.5MG | Prescription | |||
| NDA022037 - TAKEDA PHARMS USA | |||||||
| INTUNIV | GUANFACINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 1MG BASE | Prescription | |||
| INTUNIV | GUANFACINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 2MG BASE | Prescription | |||
| INTUNIV | GUANFACINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 3MG BASE | Prescription | |||
| INTUNIV | GUANFACINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 4MG BASE | Prescription | |||
| NDA022024 - TAKEDA PHARMS USA | |||||||
| ACTOPLUS MET XR | METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 1GM;EQ 15MG BASE | Discontinued | |||
| ACTOPLUS MET XR | METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 1GM;EQ 30MG BASE | Discontinued | |||
| NDA022000 - TAKEDA PHARMS USA | |||||||
| LIALDA | MESALAMINE | TABLET, DELAYED RELEASE;ORAL | 1.2GM | Prescription | |||
| NDA021977 - TAKEDA PHARMS USA | |||||||
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | CAPSULE;ORAL | 70MG | Prescription | |||
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | CAPSULE;ORAL | 20MG | Prescription | |||
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | CAPSULE;ORAL | 60MG | Prescription | |||
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | CAPSULE;ORAL | 10MG | Prescription | |||
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | CAPSULE;ORAL | 50MG | Prescription | |||
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | CAPSULE;ORAL | 30MG | Prescription | |||
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | CAPSULE;ORAL | 40MG | Prescription | |||
| NDA021925 - TAKEDA PHARMS USA | |||||||
| DUETACT | GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE | TABLET;ORAL | 2MG;30MG | Prescription | |||
| DUETACT | GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE | TABLET;ORAL | 4MG;30MG | Prescription | |||
| NDA021856 - TAKEDA PHARMS USA | |||||||
| ULORIC | FEBUXOSTAT | TABLET;ORAL | 80MG | Prescription | |||
| ULORIC | FEBUXOSTAT | TABLET;ORAL | 40MG | Prescription | |||
| NDA021842 - TAKEDA PHARMS USA | |||||||
| ACTOPLUS MET | METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE | TABLET;ORAL | 500MG;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| ACTOPLUS MET | METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE | TABLET;ORAL | 850MG;EQ 15MG BASE | Prescription | |||
| NDA021782 - TAKEDA PHARMS USA | |||||||
| ROZEREM | RAMELTEON | TABLET;ORAL | 8MG | Prescription | |||
| NDA021602 - TAKEDA PHARMS USA | |||||||
| VELCADE | BORTEZOMIB | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 3.5MG/VIAL | Prescription | |||
| NDA021566 - TAKEDA PHARMS NA | |||||||
| PREVACID IV | LANSOPRAZOLE | INJECTABLE;INTRAVENOUS | 30MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA021507 - TAKEDA PHARMS NA | |||||||
| PREVACID NAPRAPAC 250 (COPACKAGED) | LANSOPRAZOLE; NAPROXEN | CAPSULE, DELAYED REL PELLETS, TABLET;ORAL | 15MG,N/A;N/A,250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| PREVACID NAPRAPAC 375 (COPACKAGED) | LANSOPRAZOLE; NAPROXEN | CAPSULE, DELAYED REL PELLETS, TABLET;ORAL | 15MG,N/A;N/A,375MG | Discontinued | |||
| PREVACID NAPRAPAC 500 (COPACKAGED) | LANSOPRAZOLE; NAPROXEN | CAPSULE, DELAYED REL PELLETS, TABLET;ORAL | 15MG,N/A;N/A,500MG | Discontinued | |||
| NDA021468 - TAKEDA PHARMS USA | |||||||
| FOSRENOL | LANTHANUM CARBONATE | TABLET, CHEWABLE;ORAL | EQ 250MG BASE | Discontinued | |||
| FOSRENOL | LANTHANUM CARBONATE | TABLET, CHEWABLE;ORAL | EQ 500MG BASE | Prescription | |||
| FOSRENOL | LANTHANUM CARBONATE | TABLET, CHEWABLE;ORAL | EQ 750MG BASE | Prescription | |||
| FOSRENOL | LANTHANUM CARBONATE | TABLET, CHEWABLE;ORAL | EQ 1GM BASE | Prescription | |||
| NDA021428 - TAKEDA PHARMS USA | |||||||
| PREVACID | LANSOPRAZOLE | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 15MG | Prescription | |||
| PREVACID | LANSOPRAZOLE | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 30MG | Prescription | |||
| NDA021303 - TAKEDA PHARMS USA | |||||||
| ADDERALL XR 10 | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 2.5MG;2.5MG;2.5MG;2.5MG | Prescription | |||
| ADDERALL XR 20 | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 5MG;5MG;5MG;5MG | Prescription | |||
| ADDERALL XR 30 | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 7.5MG;7.5MG;7.5MG;7.5MG | Prescription | |||
| ADDERALL XR 25 | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 6.25MG;6.25MG;6.25MG;6.25MG | Prescription | |||
| ADDERALL XR 5 | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 1.25MG;1.25MG;1.25MG;1.25MG | Prescription | |||
| ADDERALL XR 15 | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 3.75MG;3.75MG;3.75MG;3.75MG | Prescription | |||
| NDA021281 - TAKEDA PHARMS NA | |||||||
| PREVACID | LANSOPRAZOLE | FOR SUSPENSION, DELAYED RELEASE;ORAL | 15MG/PACKET | Discontinued | |||
| PREVACID | LANSOPRAZOLE | FOR SUSPENSION, DELAYED RELEASE;ORAL | 30MG/PACKET | Discontinued | |||
| NDA021073 - TAKEDA PHARMS USA | |||||||
| ACTOS | PIOGLITAZONE HYDROCHLORIDE | TABLET;ORAL | EQ 45MG BASE | Prescription | |||
| ACTOS | PIOGLITAZONE HYDROCHLORIDE | TABLET;ORAL | EQ 30MG BASE | Prescription | |||
| ACTOS | PIOGLITAZONE HYDROCHLORIDE | TABLET;ORAL | EQ 15MG BASE | Prescription | |||
| NDA020712 - TAKEDA PHARMS USA | |||||||
| CARBATROL | CARBAMAZEPINE | CAPSULE, EXTENDED RELEASE;ORAL | 200MG | Prescription | |||
| CARBATROL | CARBAMAZEPINE | CAPSULE, EXTENDED RELEASE;ORAL | 300MG | Prescription | |||
| CARBATROL | CARBAMAZEPINE | CAPSULE, EXTENDED RELEASE;ORAL | 100MG | Prescription | |||
| NDA020406 - TAKEDA PHARMS USA | |||||||
| PREVACID | LANSOPRAZOLE | CAPSULE, DELAYED REL PELLETS;ORAL | 30MG | Prescription | |||
| PREVACID | LANSOPRAZOLE | CAPSULE, DELAYED REL PELLETS;ORAL | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA020333 - TAKEDA PHARMS USA | |||||||
| AGRYLIN | ANAGRELIDE HYDROCHLORIDE | CAPSULE;ORAL | EQ 0.5MG BASE | Prescription | |||
| AGRYLIN | ANAGRELIDE HYDROCHLORIDE | CAPSULE;ORAL | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA020049 - TAKEDA PHARMS USA | |||||||
| PENTASA | MESALAMINE | CAPSULE, EXTENDED RELEASE;ORAL | 500MG | Prescription | |||
| PENTASA | MESALAMINE | CAPSULE, EXTENDED RELEASE;ORAL | 250MG | Prescription | |||
| NDA019815 - TAKEDA PHARMS USA | |||||||
| PROAMATINE | MIDODRINE HYDROCHLORIDE | TABLET;ORAL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| PROAMATINE | MIDODRINE HYDROCHLORIDE | TABLET;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| PROAMATINE | MIDODRINE HYDROCHLORIDE | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||