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Details for New Drug Application (NDA): 020638

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NDA 020638 describes VISTIDE, which is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from one supplier. Additional details are available on the VISTIDE profile page.

The generic ingredient in VISTIDE is cidofovir. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cidofovir profile page.

Summary for NDA: 020638

Gilead Sciences Inc
Therapeutic Class:Antivirals

Pharmacology for NDA: 020638

Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors

Suppliers and Packaging for NDA: 020638

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INJECTABLE;INJECTION 020638 NDA Gilead Sciences, Inc. 61958-0101 61958-0101-1 1 VIAL, SINGLE-USE in 1 CARTON (61958-0101-1) > 5 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 75MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jun 26, 1996TE:RLD:No

Expired Orange Book Patents for NDA: 020638

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead Sciences Inc
INJECTABLE;INJECTION020638-001Jun 26, 19965,142,051<subscribe>
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