Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075969
Company: MYLAN PHARMS INC
Company: MYLAN PHARMS INC
| 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 |
|---|---|---|---|---|---|---|---|
| 01/29/2002 | 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-12 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/14/2019 | SUPPL-11 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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| 06/08/2007 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 06/18/2004 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 01/02/2003 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 11/06/2002 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |