Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070437
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IBUPROFEN | IBUPROFEN | 600MG | 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 |
|---|---|---|---|---|---|---|---|
| 08/21/1985 | 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 |
|---|---|---|---|---|---|
| 05/06/2016 | SUPPL-24 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/09/2016 | SUPPL-23 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/09/1991 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 05/22/1991 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 11/19/1990 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/07/1991 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/12/1989 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 06/29/1990 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/24/1989 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 01/30/1992 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/30/1992 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/08/1988 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 04/04/1988 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 01/30/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/28/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/30/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/29/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |