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Generated: August 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079081

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NDA 079081 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-seven 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: 079081

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 079081

Suppliers and Packaging for NDA: 079081

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LAMIVUDINE AND ZIDOVUDINE
lamivudine; zidovudine
TABLET;ORAL 079081 ANDA Teva Pharmaceuticals USA, Inc. 0093-5385 0093-5385-06 60 TABLET, FILM COATED in 1 BOTTLE (0093-5385-06)
LAMIVUDINE AND ZIDOVUDINE
lamivudine; zidovudine
TABLET;ORAL 079081 ANDA Rebel Distributors Corp 21695-996 21695-996-02 2 TABLET, FILM COATED in 1 BOTTLE (21695-996-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG;300MG
Approval Date:May 25, 2011TE:ABRLD:No


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