Drugs@FDA: FDA-Approved Drugs
Company: WATSON LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;SUBLINGUAL | Discontinued | None | No | No |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 |
---|---|---|---|---|---|---|---|
02/26/1988 | 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-30 | Labeling |
Label is not available on this site. |
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08/25/1992 | SUPPL-29 | Labeling |
Label is not available on this site. |
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04/02/1992 | SUPPL-28 | Labeling |
Label is not available on this site. |
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09/12/1991 | SUPPL-27 | Labeling |
Label is not available on this site. |
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11/19/1990 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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08/07/1991 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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02/13/1991 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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02/13/1991 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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06/29/1990 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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06/13/1988 | SUPPL-20 | Labeling |
Label is not available on this site. |
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06/17/1985 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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02/25/1985 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |