Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076706
Company: APOTEX
Company: APOTEX
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 |
METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 750MG | 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 |
---|---|---|---|---|---|---|---|
12/14/2004 | 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 |
---|---|---|---|---|---|
03/01/2019 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
03/01/2019 | SUPPL-14 | Labeling-Patient Package Insert, Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label is not available on this site. |
||
12/30/2009 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
02/11/2008 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
11/07/2006 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
12/29/2005 | SUPPL-1 | Labeling |
Label is not available on this site. |