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Generated: May 22, 2017

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Details for New Drug Application (NDA): 020933

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NDA 020933 describes VIRAMUNE, which is a drug marketed by Boehringer Ingelheim and is included in three NDAs. It is available from four suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the VIRAMUNE profile page.

The generic ingredient in VIRAMUNE is nevirapine. There are twenty drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the nevirapine profile page.

Summary for NDA: 020933

Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 020933

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUSPENSION;ORAL 020933 NDA AUTHORIZED GENERIC Roxane Laboratories, Inc. 0054-0450 0054-0450-58 1 BOTTLE, PLASTIC in 1 CARTON (0054-0450-58) > 240 mL in 1 BOTTLE, PLASTIC
SUSPENSION;ORAL 020933 NDA Boehringer Ingelheim Pharmaceuticals Inc. 0597-0047 0597-0047-24 1 BOTTLE, PLASTIC in 1 CARTON (0597-0047-24) > 240 mL in 1 BOTTLE, PLASTIC

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength50MG/5ML
Approval Date:Sep 11, 1998TE:AARLD:Yes

Expired Orange Book Patents for NDA: 020933

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim
SUSPENSION;ORAL020933-001Sep 11, 19985,366,972*PED► Subscribe
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