Drugs@FDA: FDA-Approved Drugs
Company: STRIDES PHARMA
| 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 |
|---|---|---|---|---|---|---|---|
| 08/06/1985 | 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 |
|---|---|---|---|---|---|
| 04/28/2021 | SUPPL-40 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 07/22/2019 | SUPPL-39 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/09/2016 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/13/1998 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/14/1997 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/1994 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/07/1994 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/10/1992 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 06/11/1991 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 02/21/1989 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 03/02/1989 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/02/1989 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/02/1989 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/31/1987 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/10/1988 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/22/1987 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/22/1987 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/02/1988 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/02/1988 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/22/1987 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/11/1986 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/16/1986 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/26/1985 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |