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Last Updated: June 10, 2023

Details for New Drug Application (NDA): 020892

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NDA 020892 describes VALSTAR PRESERVATIVE FREE, which is a drug marketed by Endo Pharm and is included in one NDA. It is available from one supplier. Additional details are available on the VALSTAR PRESERVATIVE FREE profile page.

The generic ingredient in VALSTAR PRESERVATIVE FREE is valrubicin. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the valrubicin profile page.
Summary for 020892
Applicant:Endo Pharm
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 020892
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALSTAR PRESERVATIVE FREE valrubicin SOLUTION;INTRAVESICAL 020892 NDA Endo Pharmaceuticals Solutions Inc. 67979-001 67979-001-01 4 VIAL in 1 CARTON (67979-001-01) / 5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVESICALStrength40MG/ML
Approval Date:Sep 25, 1998TE:AORLD:Yes

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