Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016776
Company: ASTRAZENECA
Company: ASTRAZENECA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SORBITRATE | ISOSORBIDE DINITRATE | 5MG | TABLET, CHEWABLE;ORAL | Discontinued | None | No | No |
| SORBITRATE | ISOSORBIDE DINITRATE | 10MG | TABLET, CHEWABLE;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 |
|---|---|---|---|---|---|---|---|
| 12/07/1970 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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-36 | Labeling |
Label is not available on this site. |
||
| 10/11/1996 | SUPPL-35 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/01/1996 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/21/1982 | SUPPL-23 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 11/28/1977 | SUPPL-15 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |