Viatris Inc. (VTRS)
FDA Applications
Note: This list only includes applications that have been responded to by the FDA.
| Application | Product Name | Active Ingredient | Form | Strength | Status | ||
|---|---|---|---|---|---|---|---|
| NDA203109 - VIATRIS | |||||||
| REVATIO | SILDENAFIL CITRATE | FOR SUSPENSION;ORAL | EQ 10MG BASE/ML | Prescription | |||
| ANDA084349 - VIATRIS | |||||||
| DILANTIN | PHENYTOIN SODIUM | CAPSULE;ORAL | 30MG EXTENDED | Prescription | |||
| DILANTIN | PHENYTOIN SODIUM | CAPSULE;ORAL | 100MG EXTENDED | Prescription | |||
| NDA022473 - VIATRIS | |||||||
| REVATIO | SILDENAFIL CITRATE | SOLUTION;INTRAVENOUS | EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) | Prescription | |||
| NDA021845 - VIATRIS | |||||||
| REVATIO | SILDENAFIL CITRATE | TABLET;ORAL | EQ 20MG BASE | Prescription | |||
| NDA021269 - VIATRIS | |||||||
| CARDURA XL | DOXAZOSIN MESYLATE | TABLET, EXTENDED RELEASE;ORAL | EQ 8MG BASE | Prescription | |||
| CARDURA XL | DOXAZOSIN MESYLATE | TABLET, EXTENDED RELEASE;ORAL | EQ 4MG BASE | Prescription | |||
| NDA021134 - VIATRIS | |||||||
| NITROSTAT | NITROGLYCERIN | TABLET;SUBLINGUAL | 0.3MG | Prescription | |||
| NITROSTAT | NITROGLYCERIN | TABLET;SUBLINGUAL | 0.6MG | Prescription | |||
| NITROSTAT | NITROGLYCERIN | TABLET;SUBLINGUAL | 0.4MG | Prescription | |||
| NDA021129 - VIATRIS | |||||||
| NEURONTIN | GABAPENTIN | SOLUTION;ORAL | 250MG/5ML | Prescription | |||
| NDA020990 - VIATRIS | |||||||
| ZOLOFT | SERTRALINE HYDROCHLORIDE | CONCENTRATE;ORAL | EQ 20MG BASE/ML | Prescription | |||
| NDA020919 - VIATRIS | |||||||
| GEODON | ZIPRASIDONE MESYLATE | POWDER;INTRAMUSCULAR | EQ 20MG BASE/VIAL | Prescription | |||
| NDA020895 - VIATRIS | |||||||
| VIAGRA | SILDENAFIL CITRATE | TABLET;ORAL | EQ 25MG BASE | Prescription | |||
| VIAGRA | SILDENAFIL CITRATE | TABLET;ORAL | EQ 50MG BASE | Prescription | |||
| VIAGRA | SILDENAFIL CITRATE | TABLET;ORAL | EQ 100MG BASE | Prescription | |||
| NDA020882 - VIATRIS | |||||||
| NEURONTIN | GABAPENTIN | TABLET;ORAL | 800MG | Prescription | |||
| NEURONTIN | GABAPENTIN | TABLET;ORAL | 600MG | Prescription | |||
| NDA020825 - VIATRIS | |||||||
| GEODON | ZIPRASIDONE HYDROCHLORIDE | CAPSULE;ORAL | EQ 20MG BASE | Prescription | |||
| GEODON | ZIPRASIDONE HYDROCHLORIDE | CAPSULE;ORAL | EQ 40MG BASE | Prescription | |||
| GEODON | ZIPRASIDONE HYDROCHLORIDE | CAPSULE;ORAL | EQ 60MG BASE | Prescription | |||
| GEODON | ZIPRASIDONE HYDROCHLORIDE | CAPSULE;ORAL | EQ 80MG BASE | Prescription | |||
| NDA020235 - VIATRIS | |||||||
| NEURONTIN | GABAPENTIN | CAPSULE;ORAL | 400MG | Prescription | |||
| NEURONTIN | GABAPENTIN | CAPSULE;ORAL | 300MG | Prescription | |||
| NEURONTIN | GABAPENTIN | CAPSULE;ORAL | 100MG | Prescription | |||
| NDA019839 - VIATRIS | |||||||
| ZOLOFT | SERTRALINE HYDROCHLORIDE | TABLET;ORAL | EQ 50MG BASE | Prescription | |||
| ZOLOFT | SERTRALINE HYDROCHLORIDE | TABLET;ORAL | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| ZOLOFT | SERTRALINE HYDROCHLORIDE | TABLET;ORAL | EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| ZOLOFT | SERTRALINE HYDROCHLORIDE | TABLET;ORAL | EQ 100MG BASE | Prescription | |||
| ZOLOFT | SERTRALINE HYDROCHLORIDE | TABLET;ORAL | EQ 25MG BASE | Prescription | |||
| NDA019787 - VIATRIS | |||||||
| NORVASC | AMLODIPINE BESYLATE | TABLET;ORAL | EQ 2.5MG BASE | Prescription | |||
| NORVASC | AMLODIPINE BESYLATE | TABLET;ORAL | EQ 5MG BASE | Prescription | |||
| NORVASC | AMLODIPINE BESYLATE | TABLET;ORAL | EQ 10MG BASE | Prescription | |||
| NDA019668 - VIATRIS | |||||||
| CARDURA | DOXAZOSIN MESYLATE | TABLET;ORAL | EQ 1MG BASE | Prescription | |||
| CARDURA | DOXAZOSIN MESYLATE | TABLET;ORAL | EQ 2MG BASE | Prescription | |||
| CARDURA | DOXAZOSIN MESYLATE | TABLET;ORAL | EQ 8MG BASE | Prescription | |||
| CARDURA | DOXAZOSIN MESYLATE | TABLET;ORAL | EQ 4MG BASE | Prescription | |||
| NDA008762 - VIATRIS | |||||||
| DILANTIN-125 | PHENYTOIN | SUSPENSION;ORAL | 125MG/5ML | Prescription | |||
| DILANTIN-30 | PHENYTOIN | SUSPENSION;ORAL | 30MG/5ML | Discontinued | |||