Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077336
Company: SUN PHARM INDS (IN)

Products on ANDA 077336

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077336

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/09/2006	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
03/01/2019	SUPPL-15	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
03/01/2019	SUPPL-12	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
09/28/2015	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
11/19/2010	SUPPL-4	Labeling		Label is not available on this site.
11/07/2007	SUPPL-1	Labeling		Label is not available on this site.