Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072407
Company: WATSON LABS TEVA
Company: WATSON LABS TEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FENOPROFEN CALCIUM | FENOPROFEN CALCIUM | EQ 600MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 06/13/1988 | 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 |
|---|---|---|---|---|---|
| 05/11/2016 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/09/2016 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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| 01/31/1997 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/07/1991 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 05/24/1989 | SUPPL-6 | Bioequivalence |
Label is not available on this site. |
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| 04/21/1989 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 07/11/1989 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/12/1989 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/11/1989 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/31/1989 | SUPPL-1 | Labeling |
Label is not available on this site. |