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Generated: May 23, 2017

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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 one supplier. Additional details are available on the ZIRGAN profile page.

The generic ingredient in ZIRGAN is ganciclovir. There are twenty-four 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 NDA: 022211

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 022211

Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors

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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