Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070475
Company: MCNEIL
Company: MCNEIL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MEDIPREN | 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 |
|---|---|---|---|---|---|---|---|
| 09/24/1986 | 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 |
|---|---|---|---|---|---|
| 02/03/1989 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/06/1989 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 09/07/1988 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 12/23/1987 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/21/1988 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/21/1988 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/17/1988 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/17/1988 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/17/1988 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/16/1987 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/16/1987 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1987 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/05/1986 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/05/1986 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/05/1986 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/16/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/16/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/16/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |