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Last Updated: May 31, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078119


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NDA 078119 describes ABACAVIR SULFATE, which is a drug marketed by Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, Apotex Inc, Cipla, Mylan Pharms Inc, Strides Pharma, Lupin Ltd, Teva Pharms Usa, and Zydus Pharms, and is included in fifteen 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 twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the abacavir sulfate; lamivudine; zidovudine profile page.
Summary for 078119
Tradename:ABACAVIR SULFATE
Applicant:Cipla
Ingredient:abacavir sulfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078119
Suppliers and Packaging for NDA: 078119
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ABACAVIR SULFATE abacavir sulfate TABLET;ORAL 078119 ANDA Cipla USA Inc. 69097-514 69097-514-03 60 TABLET, FILM COATED in 1 BOTTLE (69097-514-03)
ABACAVIR SULFATE abacavir sulfate TABLET;ORAL 078119 ANDA REMEDYREPACK INC. 70518-1274 70518-1274-0 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1274-0)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 300MG BASE
Approval Date:Nov 21, 2017TE:ABRLD:No

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