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. |
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10/11/1996 | SUPPL-35 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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04/01/1996 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
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01/21/1982 | SUPPL-23 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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11/28/1977 | SUPPL-15 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |