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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice

Generated: March 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201107

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NDA 201107 describes ABACAVIR SULFATE, which is a drug marketed by Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, Apotex Inc, Cipla Ltd, Mylan Pharms Inc, Strides Pharma, Lupin Ltd, and Teva Pharms Usa, and is included in thirteen NDAs. It is available from twelve suppliers. Additional details are available on the ABACAVIR SULFATE profile page.

The generic ingredient in ABACAVIR SULFATE is abacavir sulfate; lamivudine; zidovudine. There are eleven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the abacavir sulfate; lamivudine; zidovudine profile page.
Summary for 201107
Applicant:Hetero Labs Ltd Iii
Ingredient:abacavir sulfate
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 201107
Suppliers and Packaging for NDA: 201107
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ABACAVIR SULFATE abacavir sulfate SOLUTION;ORAL 201107 ANDA Camber Pharmaceuticals, Inc. 31722-562 N 31722-562-24

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrengthEQ 20MG BASE/ML
Approval Date:Sep 26, 2016TE:AARLD:No
Regulatory Exclusivity Expiration:Mar 14, 2018
Regulatory Exclusivity Use:PATENT CHALLENGE

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Argus Health
Federal Trade Commission
US Army
Fish and Richardson

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