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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 091560

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NDA 091560 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 091560

Tradename:	ABACAVIR SULFATE
Applicant:	Hetero Labs Ltd Iii
Ingredient:	abacavir sulfate
Patents:	0

Pharmacology for NDA: 091560

Mechanism of Action	Cytochrome P450 1A1 Inhibitors Nucleoside Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 091560

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ABACAVIR SULFATE	abacavir sulfate	TABLET;ORAL	091560	ANDA	Camber Pharmaceuticals, Inc.	31722-557	31722-557-60	60 TABLET in 1 BOTTLE (31722-557-60)
ABACAVIR SULFATE	abacavir sulfate	TABLET;ORAL	091560	ANDA	AvPAK	50268-049	50268-049-12	20 BLISTER PACK in 1 BOX (50268-049-12) / 1 TABLET in 1 BLISTER PACK (50268-049-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 300MG BASE
Approval Date:	Sep 13, 2013	TE:	AB	RLD:	No

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