Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087545
Company: SUN PHARM INDUSTRIES
Company: SUN PHARM INDUSTRIES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 10MG | TABLET;SUBLINGUAL | Discontinued | None | No | No |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/01/1998 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/11/1994 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/03/1992 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/16/1992 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 04/03/1992 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/19/1991 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 07/25/1990 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 03/07/1990 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 04/02/1987 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/16/1985 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/13/1984 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |