Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076172
Company: ACTAVIS LABS FL INC
Company: ACTAVIS LABS FL INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 06/16/2004 | 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 |
|---|---|---|---|---|---|
| 02/26/2019 | SUPPL-27 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 02/26/2019 | SUPPL-25 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 10/31/2008 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 05/25/2007 | SUPPL-6 | Labeling |
Label is not available on this site. |