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Generated: November 13, 2018

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Details for New Drug Application (NDA): 209512

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NDA 209512 describes NORVIR, which is a drug marketed by Abbott, Abbvie, and Abbvie Inc, and is included in five NDAs. It is available from five suppliers. There are nine patents protecting this drug and two Paragraph IV challenges. Additional details are available on the NORVIR profile page.

The generic ingredient in NORVIR is ritonavir. There are twenty-one drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the ritonavir profile page.
Summary for 209512
Tradename:NORVIR
Applicant:Abbvie Inc
Ingredient:ritonavir
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 209512
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NORVIR ritonavir POWDER;ORAL 209512 NDA AbbVie Inc. 0074-3399 0074-3399-30 30 PACKET in 1 CARTON (0074-3399-30) > 1 POWDER in 1 PACKET

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;ORALStrength100MG/PACKET
Approval Date:Jun 7, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 7, 2024
Regulatory Exclusivity Use:INDICATED IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS FOR THE TREATMENT OF PEDIATRIC PATIENTS WITH HIV-1 INFECTION

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