Drugs@FDA: FDA-Approved Drugs
Company: ANI PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ISOSORBIDE DINITRATE | 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 |
---|---|---|---|---|---|---|---|
01/07/1988 | 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 |
---|---|---|---|---|---|
12/10/1996 | SUPPL-34 | Labeling |
Label is not available on this site. |
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11/16/1992 | SUPPL-33 | Labeling |
Label is not available on this site. |
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04/02/1992 | SUPPL-32 | Labeling |
Label is not available on this site. |
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12/19/1991 | SUPPL-31 | Labeling |
Label is not available on this site. |
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09/12/1991 | SUPPL-30 | Labeling |
Label is not available on this site. |
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11/19/1990 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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08/07/1991 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
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06/29/1990 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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06/13/1988 | SUPPL-26 | Labeling |
Label is not available on this site. |
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03/29/1988 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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03/29/1988 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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03/29/1988 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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06/17/1985 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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02/25/1985 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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07/20/1982 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |