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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 077844


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NDA 077844 describes ABACAVIR SULFATE, which is a drug marketed by Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, Apotex Inc, Cipla, Mylan Pharms Inc, Strides Pharma, Norvium Bioscience, Aurobindo Pharma, Chartwell Rx, Laurus, Teva Pharms Usa, Zydus Pharms, and Lupin Ltd, and is included in seventeen 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. One supplier is listed for this compound. Additional details are available on the abacavir sulfate; lamivudine; zidovudine profile page.
Summary for 077844
Tradename:ABACAVIR SULFATE
Applicant:Aurobindo Pharma Ltd
Ingredient:abacavir sulfate
Patents:0
Pharmacology for NDA: 077844
Suppliers and Packaging for NDA: 077844
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ABACAVIR SULFATE abacavir sulfate TABLET;ORAL 077844 ANDA Major Pharmaceuticals 0904-6874 0904-6874-04 30 BLISTER PACK in 1 CARTON (0904-6874-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK
ABACAVIR SULFATE abacavir sulfate TABLET;ORAL 077844 ANDA Major Pharmaceuticals 0904-6874 0904-6874-06 50 BLISTER PACK in 1 CARTON (0904-6874-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 300MG BASE
Approval Date:Dec 17, 2012TE:ABRLD:No

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