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Generated: December 13, 2017

DrugPatentWatch Database Preview

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 two suppliers. Additional details are available on the VITRASE profile page.

The generic ingredient in VITRASE 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 021640

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 021640

Ingredient-typeGlycoside Hydrolases

Medical Subject Heading (MeSH) Categories for 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 24208-002-01 6 VIAL, SINGLE-USE in 1 CARTON (24208-002-01) > 1.2 mL in 1 VIAL, SINGLE-USE
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

Summary for product number 001

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

Summary for product number 002

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


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Farmers Insurance

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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