Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075976
Company: MYLAN
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET;ORAL | Discontinued | None | No | No |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 850MG | TABLET;ORAL | Discontinued | None | No | No |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | 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 |
|---|---|---|---|---|---|---|---|
| 01/24/2002 | 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 |
|---|---|---|---|---|---|
| 11/14/2019 | SUPPL-21 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/14/2019 | SUPPL-20 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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| 09/29/2010 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 03/08/2007 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 09/21/2004 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 05/14/2004 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 08/14/2003 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 10/03/2002 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/11/2002 | SUPPL-1 | Labeling |
Label is not available on this site. |