Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076038
Company: SUN PHARM INDUSTRIES
Company: SUN PHARM INDUSTRIES
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 |
---|---|---|---|---|---|---|---|
02/21/2002 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76038.APF.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/13/2008 | SUPPL-29 | Labeling |
Label is not available on this site. |
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03/16/2007 | SUPPL-24 | Labeling |
Label is not available on this site. |
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04/20/2005 | SUPPL-18 | Labeling |
Label is not available on this site. |
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08/13/2002 | SUPPL-4 | Labeling |
Label is not available on this site. |
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12/12/2002 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/12/2002 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/12/2002 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |