Drugs@FDA: FDA-Approved Drugs
Company: HERITAGE PHARMA
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 |
---|---|---|---|---|---|---|---|
01/25/2002 | 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 |
---|---|---|---|---|---|
02/22/2019 | SUPPL-34 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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02/22/2019 | SUPPL-33 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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03/19/2009 | SUPPL-27 | Labeling |
Label is not available on this site. |
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03/12/2009 | SUPPL-26 | Labeling |
Label is not available on this site. |
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06/30/2012 | SUPPL-19 | Labeling |
Label is not available on this site. |
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04/18/2007 | SUPPL-9 | Labeling |
Label is not available on this site. |
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01/03/2007 | SUPPL-8 | Labeling |
Label is not available on this site. |
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08/06/2004 | SUPPL-7 | Labeling |
Label is not available on this site. |
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01/02/2003 | SUPPL-5 | Labeling |
Label is not available on this site. |
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11/05/2002 | SUPPL-4 | Labeling |
Label is not available on this site. |
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09/04/2002 | SUPPL-2 | Labeling |
Label is not available on this site. |
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11/05/2002 | SUPPL-1 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |