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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201920
Company: TEVA PHARMS USA

Products on ANDA 201920

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VARENICLINE	VARENICLINE	0.5MG	TABLET; ORAL	None (Tentative Approval)	None	No	No
VARENICLINE	VARENICLINE	1MG	TABLET; ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201920

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/10/2013	ORIG-1	Tentative Approval	Not Applicable			Label is not available on this site.

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