Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070435
Company: WATSON LABS
Company: WATSON LABS
| 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 |
|---|---|---|---|---|---|---|---|
| 03/05/1986 | 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 |
|---|---|---|---|---|---|
| 06/08/1989 | SUPPL-35 | Bioequivalence |
Label is not available on this site. |
||
| 11/19/1990 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/29/1990 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/30/1992 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/30/1992 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/23/1992 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/20/1986 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/20/1986 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/20/1986 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/20/1986 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/25/1986 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/25/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/30/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |