Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086031
Company: WATSON LABS TEVA
Company: WATSON LABS TEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;SUBLINGUAL | Discontinued | None | No | No |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 |
|---|---|---|---|---|---|---|---|
| 09/29/1987 | 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-23 | 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-17 | 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. |