Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019091
Company: PROMIUS PHARMA
Company: PROMIUS PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ISMO | ISOSORBIDE MONONITRATE | 20MG | TABLET;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/30/1991 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/13/2000 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 06/16/1999 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 01/13/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/10/1997 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 04/08/1994 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/20/1993 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/26/1993 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |