Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075979
Company: WATSON LABS
Company: WATSON LABS
| 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 |
|---|---|---|---|---|---|
| 03/04/2005 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 04/01/2004 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 08/13/2002 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 10/11/2002 | SUPPL-5 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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| 04/22/2002 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 02/27/2003 | SUPPL-3 | Labeling |
Label is not available on this site. |