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Generated: May 25, 2019

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Details for New Drug Application (NDA): 021640

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NDA 021640 describes VITRASE, which is a drug marketed by Bausch And Lomb and is included in two NDAs. It is available from one supplier. Additional details are available on the VITRASE profile page.

The generic ingredient in VITRASE is ganciclovir. There are twenty-seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the ganciclovir profile page.
Summary for 021640
Applicant:Bausch And Lomb
Formulation / Manufacturing:see details
Pharmacology for NDA: 021640
Suppliers and Packaging for NDA: 021640
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VITRASE hyaluronidase INJECTABLE;INJECTION 021640 NDA Bausch & Lomb Incorporated 24208-002 24208-002-02 2 VIAL, SINGLE-USE in 1 CARTON (24208-002-02) > 1.2 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength6,200 UNITS/VIAL
Approval Date:May 5, 2004TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200 UNITS/VIAL
Approval Date:Dec 2, 2004TE:RLD:Yes

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