Details for New Drug Application (NDA): 079128

NDA 079128 describes LAMIVUDINE AND ZIDOVUDINE, which is a drug marketed by Anda Repository, Aurobindo Pharma, Aurobindo Pharma Ltd, Chartwell Rx, Cipla, Hetero Labs Ltd Iii, Hetero Labs Ltd V, Lupin Ltd, Macleods Pharms Ltd, Mylan, Mylan Labs Ltd, Pharmacare, and Strides Pharma, and is included in thirteen NDAs. It is available from nine 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-nine drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the lamivudine; zidovudine profile page.

Summary for 079128

Tradename:	LAMIVUDINE AND ZIDOVUDINE
Applicant:	Strides Pharma
Ingredient:	lamivudine; zidovudine
Patents:	0

Pharmacology for NDA: 079128

Mechanism of Action

Nucleoside Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 079128

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LAMIVUDINE AND ZIDOVUDINE	lamivudine; zidovudine	TABLET;ORAL	079128	ANDA	Strides Pharma Science Limited	64380-707	64380-707-03	60 TABLET in 1 BOTTLE (64380-707-03)
LAMIVUDINE AND ZIDOVUDINE	lamivudine; zidovudine	TABLET;ORAL	079128	ANDA	Bryant Ranch Prepack	71335-0141	71335-0141-1	6 TABLET in 1 BOTTLE (71335-0141-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	150MG;300MG
Approval Date:	May 13, 2015	TE:	AB	RLD:	No

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