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Generated: August 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079246

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NDA 079246 describes ABACAVIR SULFATE AND LAMIVUDINE, which is a drug marketed by Cipla Ltd, Teva Pharms Usa, Aurobindo Pharma Ltd, and Lupin Ltd, and is included in four NDAs. It is available from four suppliers. Additional details are available on the ABACAVIR SULFATE AND LAMIVUDINE profile page.

The generic ingredient in ABACAVIR SULFATE AND LAMIVUDINE is abacavir sulfate; lamivudine. There are eleven drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the abacavir sulfate; lamivudine profile page.

Summary for NDA: 079246

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 079246

Suppliers and Packaging for NDA: 079246

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ABACAVIR SULFATE AND LAMIVUDINE
abacavir sulfate; lamivudine
TABLET;ORAL 079246 ANDA Teva Pharmaceuticals USA, Inc. 0093-5382 0093-5382-56 1 BOTTLE in 1 CARTON (0093-5382-56) > 30 TABLET, FILM COATED in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 600MG BASE;300MG
Approval Date:Sep 29, 2016TE:ABRLD:No
Regulatory Exclusivity Expiration:Mar 28, 2017
Regulatory Exclusivity Use:PATENT CHALLENGE


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Serving 500+ biopharmaceutical companies globally:

McKesson
US Army
US Department of Justice
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Dow
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Healthtrust

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