Details for New Drug Application (NDA): 077950

NDA 077950 describes ABACAVIR SULFATE, which is a drug marketed by Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, Apotex Inc, Cipla, Mylan Pharms Inc, Strides Pharma, Norvium Bioscience, Aurobindo Pharma, Chartwell Rx, Laurus, Teva Pharms Usa, Zydus Pharms, and Lupin Ltd, and is included in seventeen 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. One supplier is listed for this compound. Additional details are available on the abacavir sulfate; lamivudine; zidovudine profile page.

Summary for 077950

Tradename:	ABACAVIR SULFATE
Applicant:	Aurobindo Pharma Ltd
Ingredient:	abacavir sulfate
Patents:	0

Pharmacology for NDA: 077950

Mechanism of Action

Cytochrome P450 1A1 Inhibitors Nucleoside Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 077950

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ABACAVIR SULFATE	abacavir sulfate	SOLUTION;ORAL	077950	ANDA	Rising Pharma Holdings, Inc.	64980-405	64980-405-24	1 BOTTLE in 1 CARTON (64980-405-24) / 240 mL in 1 BOTTLE
ABACAVIR SULFATE	abacavir sulfate	SOLUTION;ORAL	077950	ANDA	Aurobindo Pharma Limited	65862-089	65862-089-24	1 BOTTLE in 1 CARTON (65862-089-24) / 240 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	EQ 20MG BASE/ML
Approval Date:	Mar 14, 2018	TE:	AA	RLD:	No

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