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-Package Insert, Labeling-Patient 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. |
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