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Last Updated: July 29, 2021

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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. Eleven suppliers are listed for this compound. Additional details are available on the nevirapine profile page.
Summary for 201152
Applicant:Boehringer Ingelheim
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)
Paragraph IV (Patent) Challenges for 201152
Tradename Dosage Ingredient NDA Submissiondate
VIRAMUNE XR TABLET, EXTENDED RELEASE;ORAL nevirapine 201152 2013-06-21

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength400MG
Approval Date:Mar 25, 2011TE:ABRLD:Yes
Patent:⤷  Try it FreePatent Expiration:Mar 12, 2029Product Flag?Substance Flag?Delist Request?

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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