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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Deloitte
UBS
US Army
Julphar
McKinsey
Johnson and Johnson
Teva
Medtronic

Generated: April 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091560

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NDA 091560 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 091560
Tradename:ABACAVIR SULFATE
Applicant:Hetero Labs Ltd Iii
Ingredient:abacavir sulfate
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 091560
Suppliers and Packaging for NDA: 091560
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ABACAVIR SULFATE abacavir sulfate TABLET;ORAL 091560 ANDA Camber Pharmaceuticals, Inc. 31722-557 N 31722-557-60
ABACAVIR SULFATE abacavir sulfate TABLET;ORAL 091560 ANDA REMEDYREPACK INC. 52125-956 N 52125-956-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 300MG BASE
Approval Date:Sep 13, 2013TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Daiichi Sankyo
Colorcon
Julphar
Dow
Mallinckrodt
Cipla
Merck
Farmers Insurance

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