Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077114
Company: L PERRIGO CO
Company: L PERRIGO CO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IBUPROFEN | IBUPROFEN | 400MG | TABLET;ORAL | Discontinued | None | No | No |
| IBUPROFEN | IBUPROFEN | 600MG | TABLET;ORAL | Discontinued | None | No | No |
| 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 |
|---|---|---|---|---|---|---|---|
| 07/18/2005 | 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 |
|---|---|---|---|---|---|
| 04/28/2021 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/22/2019 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/09/2016 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/04/2008 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 07/03/2006 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 03/02/2006 | SUPPL-1 | Labeling |
Label is not available on this site. |