Drugs@FDA: FDA-Approved Drugs
Company: SUN PHARM INDS 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 |
---|---|---|---|---|---|
11/04/2019 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
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11/04/2019 | SUPPL-37 | Labeling-Package Insert |
Label is not available on this site. |
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09/30/2008 | SUPPL-25 | Labeling |
Label is not available on this site. |
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07/11/2007 | SUPPL-23 | Labeling |
Label is not available on this site. |
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09/04/2007 | SUPPL-20 | Labeling |
Label is not available on this site. |
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04/17/2007 | SUPPL-17 | Labeling |
Label is not available on this site. |
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07/07/2006 | SUPPL-15 | Labeling |
Label is not available on this site. |
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02/14/2005 | SUPPL-10 | Labeling |
Label is not available on this site. |
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11/01/2002 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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12/16/2002 | SUPPL-5 | Labeling |
Label is not available on this site. |
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12/16/2002 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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08/23/2002 | SUPPL-3 | Labeling |
Label is not available on this site. |
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08/23/2002 | SUPPL-2 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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08/23/2002 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |