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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 090159


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NDA 090159 describes ABACAVIR SULFATE AND LAMIVUDINE, which is a drug marketed by Norvium Bioscience, Aurobindo Pharma, Aurobindo Pharma Ltd, Chartwell Rx, Cipla, Laurus, Teva Pharms Usa, and Zydus Pharms, and is included in eight NDAs. It is available from five suppliers. Additional details are available on the ABACAVIR SULFATE AND LAMIVUDINE profile page.

The generic ingredient in ABACAVIR SULFATE AND LAMIVUDINE is abacavir sulfate; lamivudine. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the abacavir sulfate; lamivudine profile page.
Summary for 090159
Pharmacology for NDA: 090159
Suppliers and Packaging for NDA: 090159
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET;ORAL 090159 ANDA Aurobindo Pharma Limited 65862-335 65862-335-10 10 BLISTER PACK in 1 CARTON (65862-335-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET;ORAL 090159 ANDA Aurobindo Pharma Limited 65862-335 65862-335-30 1 BOTTLE in 1 CARTON (65862-335-30) / 30 TABLET, FILM COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 600MG BASE;300MG
Approval Date:Nov 15, 2018TE:ABRLD:No

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