Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086222
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 5MG | 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 |
|---|---|---|---|---|---|---|---|
| 02/19/1988 | 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 |
|---|---|---|---|---|---|
| 03/20/1995 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/21/1991 | SUPPL-29 | Labeling |
Label is not available on this site. |
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| 02/06/1990 | SUPPL-28 | Labeling |
Label is not available on this site. |
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| 11/03/1989 | SUPPL-27 | Labeling |
Label is not available on this site. |
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| 06/13/1989 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 05/08/1987 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/08/1987 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/08/1987 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/14/1986 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/17/1985 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/09/1984 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/17/1985 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/28/1982 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/28/1983 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/28/1982 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/28/1982 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/28/1983 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |