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Serving leading biopharmaceutical companies globally:

Colorcon
Mallinckrodt
Novartis
AstraZeneca
Medtronic
Harvard Business School
Baxter
Express Scripts
Queensland Health
Covington

Generated: February 23, 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 Hetero Labs Ltd Iii, Apotex Inc, Aurobindo Pharma Ltd, Cipla Ltd, Mylan Pharms Inc, Strides Pharma, Lupin Ltd, and Teva Pharms Usa, and is included in twelve 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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