Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020892
Company: ENDO PHARM

Products on NDA 20892

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VALSTAR PRESERVATIVE FREE	VALRUBICIN	40MG/ML	SOLUTION;INTRAVESICAL	Prescription	AO	Yes	Yes

Labels for NDA 020892

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/07/2016	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020892s019lbl.pdf
11/02/2011	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020892s013lbl.pdf
09/25/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20892lbl.pdf