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Last Updated: May 26, 2022

Details for New Drug Application (NDA): 079246

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NDA 079246 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 seven 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. Eight suppliers are listed for this compound. Additional details are available on the abacavir sulfate; lamivudine profile page.
Summary for 079246
Suppliers and Packaging for NDA: 079246
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET;ORAL 079246 ANDA AvKARE 42291-115 42291-115-30 1 BOTTLE in 1 CARTON (42291-115-30) > 30 TABLET, FILM COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 600MG BASE;300MG
Approval Date:Sep 29, 2016TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson

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