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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

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
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
VIRACEPT
nelfinavir mesylate
POWDER;ORAL020778-001Mar 14, 19975,484,926*PED► Subscribe
Agouron Pharms
VIRACEPT
nelfinavir mesylate
POWDER;ORAL020778-001Mar 14, 19975,952,343*PED► Subscribe
Agouron Pharms
VIRACEPT
nelfinavir mesylate
POWDER;ORAL020778-001Mar 14, 19976,162,812*PED► Subscribe
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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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