Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071644
Company: VINTAGE PHARMS
Company: VINTAGE PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IBUPROFEN | IBUPROFEN | 400MG | 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 |
|---|---|---|---|---|---|---|---|
| 02/01/1988 | 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 |
|---|---|---|---|---|---|
| 07/22/2019 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/09/2016 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/18/1991 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/18/1991 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/18/1991 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/19/1989 | SUPPL-5 | Bioequivalence |
Label is not available on this site. |
||
| 06/12/1991 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/17/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/17/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |