Drugs@FDA: FDA-Approved Drugs
Company: STRIDES PHARMA INTL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IBUPROFEN | IBUPROFEN | 800MG | 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 |
|---|---|---|---|---|---|---|---|
| 07/25/1986 | 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 |
|---|---|---|---|---|---|
| 11/21/2024 | SUPPL-36 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/28/2021 | SUPPL-35 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/22/2019 | SUPPL-34 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/09/2016 | SUPPL-33 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/13/1998 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/14/1997 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/15/1994 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/08/1994 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/10/1992 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 06/11/1991 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 02/21/1989 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 12/30/1988 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 11/22/1988 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/02/1989 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/02/1989 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/01/1988 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 02/10/1988 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/22/1987 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/02/1988 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/20/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/23/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/17/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |