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Details for New Drug Application (NDA): 020685

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NDA 020685 describes CRIXIVAN, which is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from five suppliers. There are two patents protecting this drug. Additional details are available on the CRIXIVAN profile page.

The generic ingredient in CRIXIVAN is indinavir sulfate. There are two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the indinavir sulfate profile page.

Summary for NDA: 020685

Tradename:
CRIXIVAN
Applicant:
Merck Sharp Dohme
Ingredient:
indinavir sulfate
Patents:2
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 020685

Mechanism of ActionHIV Protease Inhibitors

Suppliers and Packaging for NDA: 020685

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CRIXIVAN
indinavir sulfate
CAPSULE;ORAL 020685 NDA Merck Sharp & Dohme Corp. 0006-0571 0006-0571-43 360 CAPSULE in 1 BOTTLE (0006-0571-43)
CRIXIVAN
indinavir sulfate
CAPSULE;ORAL 020685 NDA Merck Sharp & Dohme Corp. 0006-0573 0006-0573-62 180 CAPSULE in 1 BOTTLE (0006-0573-62)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 400MG BASE
Approval Date:Mar 13, 1996TE:RLD:Yes
Patent:6,645,961Patent Expiration:Mar 4, 2018Product Flag?YSubstance Flag?Delist Request?
Patent:6,689,761Patent Expiration:Feb 10, 2021Product Flag?Substance Flag?Delist Request?
Patented Use:TREATING HIV INFECTION WITH INDINAVIR SULFATE IN COMBINATION WITH ANTIRETROVIRAL AGENTS

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 200MG BASE
Approval Date:Mar 13, 1996TE:RLD:No
Patent:6,645,961Patent Expiration:Mar 4, 2018Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 020685

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme
CRIXIVAN
indinavir sulfate
CAPSULE;ORAL020685-006Apr 19, 20005,413,999► subscribe
Merck Sharp Dohme
CRIXIVAN
indinavir sulfate
CAPSULE;ORAL020685-005Dec 17, 19985,413,999► subscribe
Merck Sharp Dohme
CRIXIVAN
indinavir sulfate
CAPSULE;ORAL020685-001Mar 13, 19965,413,999► subscribe
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