Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071999
Company: MYLAN
Company: MYLAN
| 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 |
|---|---|---|---|---|---|---|---|
| 12/03/1987 | 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 |
|---|---|---|---|---|---|
| 04/28/2021 | SUPPL-21 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/22/2019 | SUPPL-20 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 05/09/2016 | SUPPL-19 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/22/2016 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/25/1998 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/05/1998 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/05/1994 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/10/1991 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 10/31/1991 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 10/31/1991 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/24/1991 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 01/31/1990 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/21/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/21/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/21/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/04/1988 | SUPPL-1 | Labeling |
Label is not available on this site. |