Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070493
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 |
|---|---|---|---|---|---|---|---|
| 12/24/1985 | 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-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1994 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/11/1994 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/18/1993 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 04/03/1992 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/03/1992 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/18/1993 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 11/01/1991 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 12/19/1988 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/02/1988 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/02/1988 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/07/1987 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1987 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1987 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/29/1986 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/29/1986 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/12/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/10/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/12/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |