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Details for New Drug Application (NDA): 020636

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NDA 020636 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 nineteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. There are eight tentative approvals for this compound. Additional details are available on the nevirapine profile page.

Summary for NDA: 020636

Boehringer Ingelheim
Therapeutic Class:Antivirals

Suppliers and Packaging for NDA: 020636

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 020636 NDA AUTHORIZED GENERIC Roxane Laboratories, Inc. 0054-0459 0054-0459-21 60 TABLET in 1 BOTTLE (0054-0459-21)
TABLET;ORAL 020636 NDA Boehringer Ingelheim Pharmaceuticals Inc. 0597-0046 0597-0046-41 1 BLISTER PACK in 1 CARTON (0597-0046-41) > 14 TABLET in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Jun 21, 1996TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 020636

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim
TABLET;ORAL020636-001Jun 21, 19965,366,972*PED► subscribe
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