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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 091050


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NDA 091050 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 091050
Tradename:ABACAVIR SULFATE
Applicant:Strides Pharma
Ingredient:abacavir sulfate
Patents:0
Pharmacology for NDA: 091050
Suppliers and Packaging for NDA: 091050
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ABACAVIR SULFATE abacavir sulfate TABLET;ORAL 091050 ANDA Strides Pharma Science Limited 64380-717 64380-717-01 60 TABLET in 1 BLISTER PACK (64380-717-01)
ABACAVIR SULFATE abacavir sulfate TABLET;ORAL 091050 ANDA Strides Pharma Science Limited 64380-717 64380-717-03 60 TABLET in 1 BOTTLE (64380-717-03)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 300MG BASE
Approval Date:Oct 28, 2016TE:ABRLD:No

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