Last Updated: June 9, 2026

Details for New Drug Application (NDA): 091050

✉ Email this page to a colleague

« Back to Dashboard

NDA 091050 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, 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 twelve drug master file entries for this compound. Additional details are available on the abacavir sulfate; lamivudine; zidovudine profile page.

Summary for 091050

Tradename:	ABACAVIR SULFATE
Applicant:	Chartwell Rx
Ingredient:	abacavir sulfate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 300MG BASE
Approval Date:	Oct 28, 2016	TE:	AB	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.