Details for New Drug Application (NDA): 078119

NDA 078119 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 078119

Tradename:	ABACAVIR SULFATE
Applicant:	Cipla
Ingredient:	abacavir sulfate
Patents:	0

Pharmacology for NDA: 078119

Mechanism of Action

Nucleoside Reverse Transcriptase Inhibitors Cytochrome P450 1A1 Inhibitors

Suppliers and Packaging for NDA: 078119

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ABACAVIR SULFATE	abacavir sulfate	TABLET;ORAL	078119	ANDA	Cipla USA Inc.	69097-514	69097-514-03	60 TABLET, FILM COATED in 1 BOTTLE (69097-514-03)
ABACAVIR SULFATE	abacavir sulfate	TABLET;ORAL	078119	ANDA	REMEDYREPACK INC.	70518-1274	70518-1274-0	30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1274-0)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 300MG BASE
Approval Date:	Nov 21, 2017	TE:	AB	RLD:	No

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