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Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091294

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NDA 091294 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 thirteen 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 091294
Tradename:ABACAVIR SULFATE
Applicant:Mylan Pharms Inc
Ingredient:abacavir sulfate
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 091294
Suppliers and Packaging for NDA: 091294
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ABACAVIR SULFATE abacavir sulfate TABLET;ORAL 091294 ANDA Mylan Pharmaceuticals Inc. 0378-4105 N 0378-4105-91
ABACAVIR SULFATE abacavir sulfate TABLET;ORAL 091294 ANDA Mylan Institutional Inc. 51079-204 N 51079-204-06

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 300MG BASE
Approval Date:Jun 18, 2012TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

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Daiichi Sankyo
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