Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075967
Company: SUN PHARM INDS INC

Products on ANDA 075967

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075967

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