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Last Updated: May 19, 2024

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, Mylan Labs Ltd, 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 078119
Ingredient:abacavir sulfate
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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