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Drugs@FDA: FDA-Approved Drugs

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

Products on NDA 020892

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020892

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/25/1998	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20892lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20892ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20892.html

Supplements

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) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020892s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020892Orig1s019ltr.pdf
01/17/2014	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
11/12/2013	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
08/02/2013	SUPPL-16	Efficacy-Manufacturing Change With Clinical Data	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020892Orig1s016ltr.pdf
12/20/2012	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
11/02/2011	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020892s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020892s013ltr.pdf
04/24/2001	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
08/05/1999	SUPPL-1	Manufacturing (CMC)-Expiration Date		Label is not available on this site.

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

Therapeutic Equivalents for NDA 020892

VALSTAR PRESERVATIVE FREE

SOLUTION;INTRAVESICAL; 40MG/ML
TE Code = AO

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VALRUBICIN	VALRUBICIN	40MG/ML	SOLUTION;INTRAVESICAL	Prescription	No	AO	206430	HIKMA
VALSTAR PRESERVATIVE FREE	VALRUBICIN	40MG/ML	SOLUTION;INTRAVESICAL	Prescription	Yes	AO	020892	ENDO OPERATIONS

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