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Generated: November 18, 2018

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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 three 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. Eighteen suppliers are listed for this compound. Additional details are available on the nevirapine profile page.
Summary for 020933
Applicant:Boehringer Ingelheim
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 020933
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VIRAMUNE nevirapine SUSPENSION;ORAL 020933 NDA AUTHORIZED GENERIC West-Ward Pharmaceuticals Corp. 0054-0450 0054-0450-58 1 BOTTLE, PLASTIC in 1 CARTON (0054-0450-58) > 240 mL in 1 BOTTLE, PLASTIC
VIRAMUNE nevirapine 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

Profile for product number 001

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

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