Drugs@FDA: FDA-Approved Drugs
Company: ANI PHARMS
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 |
---|---|---|---|---|---|---|---|
01/20/1987 | 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 |
---|---|---|---|---|---|
05/05/1997 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/08/1990 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/25/1989 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
12/07/1990 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/11/1989 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/30/1988 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/30/1988 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/30/1988 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/06/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/08/1988 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/08/1988 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
12/16/1992 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/16/1992 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/16/1992 | SUPPL-1 | Labeling |
Label is not available on this site. |