Drugs@FDA: FDA-Approved Drugs
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. |
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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. |
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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. |
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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. |