Details for New Drug Application (NDA): 091294

NDA 091294 describes ABACAVIR SULFATE, which is a drug marketed by Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, Apotex Inc, Chartwell Rx, Cipla, Mylan Pharms Inc, Pharmobedient, Aurobindo Pharma, Hetero Labs Ltd V, Laurus, Macleods Pharms Ltd, Teva Pharms Usa, Zydus Pharms, and Lupin Ltd, and is included in nineteen NDAs. It is available from ten suppliers. Additional details are available on the ABACAVIR SULFATE profile page.

The generic ingredient in ABACAVIR SULFATE is abacavir sulfate; lamivudine; zidovudine. There are twelve drug master file entries for this compound. Additional details are available on the abacavir sulfate; lamivudine; zidovudine profile page.

Summary for 091294

Tradename:	ABACAVIR SULFATE
Applicant:	Mylan Pharms Inc
Ingredient:	abacavir sulfate
Patents:	0

Pharmacology for NDA: 091294

Mechanism of Action

Cytochrome P450 1A1 Inhibitors Nucleoside Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 091294

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ABACAVIR SULFATE	abacavir sulfate	TABLET;ORAL	091294	ANDA	Mylan Pharmaceuticals Inc.	0378-4105	0378-4105-91	1 BOTTLE, PLASTIC in 1 CARTON (0378-4105-91) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
ABACAVIR SULFATE	abacavir sulfate	TABLET;ORAL	091294	ANDA	Mylan Institutional Inc.	51079-204	51079-204-06	50 BLISTER PACK in 1 CARTON (51079-204-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-204-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 300MG BASE
Approval Date:	Jun 18, 2012	TE:	AB	RLD:	No

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