Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 218255
Company: ZYDUS PHARMS
Company: ZYDUS PHARMS
| 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 |
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 120MG | 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 |
|---|---|---|---|---|---|---|---|
| 02/15/2024 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |