Last Updated: September 24, 2026

Details for New Drug Application (NDA): 201107

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NDA 201107 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, Teva Pharms Usa, Zydus Pharms, and Lupin, and is included in nineteen NDAs. It is available from twelve suppliers. Additional details are available on the ABACAVIR SULFATE profile page.

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

Summary for 201107

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

Pharmacology for NDA: 201107

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	EQ 20MG BASE/ML
Approval Date:	Sep 26, 2016	TE:	AA	RLD:	No

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