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Last Updated: May 31, 2020

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Details for New Drug Application (NDA): 206151


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NDA 206151 describes ABACAVIR SULFATE AND LAMIVUDINE, which is a drug marketed by Aurobindo Pharma Ltd, Cipla, Lupin Ltd, Teva Pharms Usa, and Zydus Pharms, and is included in six NDAs. It is available from eight 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. Ten suppliers are listed for this compound. Additional details are available on the abacavir sulfate; lamivudine profile page.
Summary for 206151
Pharmacology for NDA: 206151
Suppliers and Packaging for NDA: 206151
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET;ORAL 206151 ANDA Burel Pharma 35573-402 35573-402-30 1 BOTTLE in 1 CARTON (35573-402-30) > 30 TABLET, FILM COATED in 1 BOTTLE
ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET;ORAL 206151 ANDA Aurobindo Pharma Limited 65862-900 65862-900-30 1 BOTTLE in 1 CARTON (65862-900-30) > 30 TABLET, FILM COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 600MG BASE;300MG
Approval Date:Mar 28, 2017TE:ABRLD:No

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