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Serving leading biopharmaceutical companies globally:

Harvard Business School
Queensland Health
Farmers Insurance
US Army

Generated: December 11, 2017

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

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 24208-535-15 1 TUBE, WITH APPLICATOR in 1 CARTON (24208-535-15) > 1.5 g in 1 TUBE, WITH APPLICATOR
ZIRGAN ganciclovir GEL;OPHTHALMIC 022211 NDA Bausch & Lomb Incorporated 24208-535 24208-535-35 1 TUBE, WITH APPLICATOR in 1 CARTON (24208-535-35) > 5 g in 1 TUBE, WITH APPLICATOR

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;OPHTHALMICStrength0.15%
Approval Date:Sep 15, 2009TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 15, 2016
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Chinese Patent Office
Fish and Richardson
Queensland Health

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