Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203689
Company: WATSON LABS TEVA

Products on ANDA 203689

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING;ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203689

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/12/2017	ORIG-1	Tentative Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203689Orig1s000TAltr.pdf