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Generated: November 17, 2018

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Details for New Drug Application (NDA): 201152

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NDA 201152 describes VIRAMUNE XR, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the VIRAMUNE XR profile page.

The generic ingredient in VIRAMUNE XR 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 201152
Tradename:VIRAMUNE XR
Applicant:Boehringer Ingelheim
Ingredient:nevirapine
Patents:1
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 201152
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VIRAMUNE XR nevirapine TABLET, EXTENDED RELEASE;ORAL 201152 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0123 0597-0123-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0123-30)
VIRAMUNE XR nevirapine TABLET, EXTENDED RELEASE;ORAL 201152 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0129 0597-0129-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0129-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength400MG
Approval Date:Mar 25, 2011TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Mar 12, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF HIV-1 BY ONCE DAILY ADMINISTRATION

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength100MG
Approval Date:Nov 8, 2012TE:ABRLD:Yes

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