Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071668
Company: PLIVA
Company: PLIVA
| 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 |
|---|---|---|---|---|---|---|---|
| 06/18/1987 | 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 |
|---|---|---|---|---|---|
| 05/09/2016 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/11/1994 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/31/1992 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 12/07/1989 | SUPPL-13 | Bioequivalence |
Label is not available on this site. |
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| 02/01/1989 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 07/05/1988 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/11/1988 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/11/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/06/1987 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/27/1987 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |