Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016192
Company: ASTRAZENECA
Company: ASTRAZENECA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SORBITRATE | ISOSORBIDE DINITRATE | 5MG | TABLET;ORAL | Discontinued | None | No | No |
| SORBITRATE | ISOSORBIDE DINITRATE | 10MG | 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 |
|---|---|---|---|---|---|---|---|
| 01/16/1968 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
|---|---|---|---|---|---|
| 01/26/1999 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 10/11/1996 | SUPPL-42 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/01/1996 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/09/1981 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 08/05/1980 | SUPPL-22 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |