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 | 400MG | 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-38 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
07/22/2019 | SUPPL-37 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
05/09/2016 | SUPPL-36 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
12/01/1998 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/23/1994 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/11/1994 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/03/1992 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/03/1992 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/11/1991 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/11/1991 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/12/1991 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
09/13/1989 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
05/17/1989 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
02/02/1989 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
12/16/1988 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/20/1988 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
03/04/1988 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/04/1988 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/27/1987 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/20/1991 | SUPPL-12 | 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. |
||
12/06/1985 | 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. |
||
09/16/1985 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |