Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070733
Company: P AND L DEV LLC
Company: P AND L DEV LLC
| 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 |
|---|---|---|---|---|---|---|---|
| 09/19/1986 | 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 |
|---|---|---|---|---|---|
| 01/28/2000 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/26/1989 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1988 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/06/1988 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 04/06/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/03/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/07/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/07/1987 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/07/1987 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/07/1987 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |