Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071462
Company: SUN PHARM INDUSTRIES
Company: SUN PHARM INDUSTRIES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IBUPROFEN | IBUPROFEN | 200MG | 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 |
|---|---|---|---|---|---|---|---|
| 10/02/1986 | 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 |
|---|---|---|---|---|---|
| 12/01/1998 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1994 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/11/1994 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/18/1993 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 05/18/1993 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 04/03/1992 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/03/1992 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/12/1995 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/12/1995 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/06/1991 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 01/05/1989 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/06/1988 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/25/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/27/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/09/1987 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/09/1987 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/09/1987 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |