Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204591
Company: TEVA PHARMS USA INC

Products on ANDA 204591

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE	SITAGLIPTIN PHOSPHATE;METFORMIN HYDROCHLORIDE	50MG;500MG	TABLET, EXTENDED RELEASE;ORAL	None (Tentative Approval)	None	No	No
SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE	SITAGLIPTIN PHOSPHATE;METFORMIN HYDROCHLORIDE	50MG;1000MG	TABLET, EXTENDED RELEASE;ORAL	None (Tentative Approval)	None	No	No
SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE	SITAGLIPTIN PHOSPHATE;METFORMIN HYDROCHLORIDE	100MG;1000MG	TABLET, EXTENDED RELEASE;ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204591

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/29/2015	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.