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Details for New Drug Application (NDA): 020778

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NDA 020778 describes VIRACEPT, which is a drug marketed by Agouron and is included in three NDAs. It is available from four suppliers. Additional details are available on the VIRACEPT profile page.

The generic ingredient in VIRACEPT is nelfinavir mesylate. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the nelfinavir mesylate profile page.

Summary for NDA: 020778

nelfinavir mesylate
Therapeutic Class:Antivirals

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:POWDER;ORALStrengthEQ 50MG BASE/SCOOPFUL
Approval Date:Mar 14, 1997TE:RLD:No

Expired Orange Book Patents for NDA: 020778

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
nelfinavir mesylate
POWDER;ORAL020778-001Mar 14, 19975,484,926*PED► subscribe
nelfinavir mesylate
POWDER;ORAL020778-001Mar 14, 19976,162,812*PED► subscribe
nelfinavir mesylate
POWDER;ORAL020778-001Mar 14, 19975,952,343*PED► subscribe
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