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Generated: May 29, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079124

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NDA 079124 describes LAMIVUDINE AND ZIDOVUDINE, which is a drug marketed by Mylan Pharms Inc, Aurobindo Pharma Ltd, Pharmacare, Hetero Labs Ltd Iii, Strides Pharma, Lupin Ltd, Hetero Labs Ltd V, and Teva Pharms, and is included in nine NDAs. It is available from twenty suppliers. Additional details are available on the LAMIVUDINE AND ZIDOVUDINE profile page.

The generic ingredient in LAMIVUDINE AND ZIDOVUDINE is lamivudine; zidovudine. There are twenty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the lamivudine; zidovudine profile page.

Summary for NDA: 079124

Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 079124

Suppliers and Packaging for NDA: 079124

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
lamivudine; zidovudine
TABLET;ORAL 079124 ANDA Camber Pharmaceuticals, Inc. 31722-506 31722-506-05 500 TABLET, FILM COATED in 1 BOTTLE (31722-506-05)
lamivudine; zidovudine
TABLET;ORAL 079124 ANDA Camber Pharmaceuticals, Inc. 31722-506 31722-506-60 60 TABLET, FILM COATED in 1 BOTTLE (31722-506-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG;300MG
Approval Date:Sep 17, 2015TE:ABRLD:No

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