Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206430
Company: HIKMA

Products on ANDA 206430

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VALRUBICIN	VALRUBICIN	40MG/ML	SOLUTION;INTRAVESICAL	Prescription	AO	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206430

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/19/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 206430

VALRUBICIN

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 PHARM