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Generated: February 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022211

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NDA 022211 describes ZIRGAN, which is a drug marketed by Bausch And Lomb and is included in one NDA. It is available from two suppliers. Additional details are available on the ZIRGAN profile page.

The generic ingredient in ZIRGAN is ganciclovir. There are twenty-five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the ganciclovir profile page.
Summary for 022211
Applicant:Bausch And Lomb
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 022211
Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors
Medical Subject Heading (MeSH) Categories for 022211
Suppliers and Packaging for NDA: 022211
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZIRGAN ganciclovir GEL;OPHTHALMIC 022211 NDA Bausch & Lomb Incorporated 24208-535 N 24208-535-35
ZIRGAN ganciclovir GEL;OPHTHALMIC 022211 NDA Bausch & Lomb Incorporated 24208-535 N 24208-535-15

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;OPHTHALMICStrength0.15%
Approval Date:Sep 15, 2009TE:RLD:Yes

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