Drugs@FDA: FDA-Approved Drugs
Company: SUN PHARM INDUSTRIES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IBUPROFEN | IBUPROFEN | 600MG | 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 |
|---|---|---|---|---|---|---|---|
| 07/24/1985 | 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 |
|---|---|---|---|---|---|
| 04/30/2021 | SUPPL-40 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/22/2019 | SUPPL-39 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 05/09/2016 | SUPPL-38 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1994 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/11/1994 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1992 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1992 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/12/1991 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 06/07/1990 | SUPPL-30 | Bioequivalence |
Label is not available on this site. |
||
| 01/10/1995 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/13/1989 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 05/17/1989 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 02/02/1989 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 12/16/1988 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/20/1988 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 03/03/1988 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/03/1988 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/31/1987 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/06/1985 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/07/1985 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/25/1985 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/06/1985 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/16/1985 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |