Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075306
Company: ACTAVIS ELIZABETH
Company: ACTAVIS ELIZABETH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 12/31/1998 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/02/2001 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/19/2001 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/01/1999 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 08/31/1999 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |