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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 Pharms 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

Agouron Pharms
nelfinavir mesylate
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

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

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