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Details for New Drug Application (NDA): 079246

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NDA 079246 describes ABACAVIR SULFATE AND LAMIVUDINE, which is a drug marketed by Teva Pharms Usa and is included in one NDA. It is available from one supplier. 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 eleven drug master file entries for this compound. Seven suppliers are listed for this compound. There are seven tentative approvals for this compound. Additional details are available on the abacavir sulfate; lamivudine profile page.

Summary for NDA: 079246

Teva Pharms Usa
abacavir sulfate; lamivudine
Therapeutic Class:Antivirals

Pharmacology for NDA: 079246

Suppliers and Packaging for NDA: 079246

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
abacavir sulfate; lamivudine
TABLET;ORAL 079246 ANDA Teva Pharmaceuticals USA, Inc. 0093-5382 0093-5382-56 1 BOTTLE in 1 CARTON (0093-5382-56) > 30 TABLET, FILM COATED in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 600MG BASE;300MG
Approval Date:Sep 29, 2016TE:ABRLD:No
Regulatory Exclusivity Expiration:Mar 29, 2017
Regulatory Exclusivity Use:PATENT CHALLENGE

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