Details for New Drug Application (NDA): 216332

NDA 216332 describes ABACAVIR SULFATE AND LAMIVUDINE, which is a drug marketed by Norvium Bioscience, Aurobindo Pharma, Aurobindo Pharma Ltd, Chartwell Rx, Cipla, Laurus, Teva Pharms Usa, and Zydus Pharms, and is included in eight NDAs. It is available from five suppliers. Additional details are available on the ABACAVIR SULFATE AND LAMIVUDINE profile page.

The generic ingredient in ABACAVIR SULFATE AND LAMIVUDINE is abacavir sulfate; lamivudine. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the abacavir sulfate; lamivudine profile page.

Summary for 216332

Tradename:	ABACAVIR SULFATE AND LAMIVUDINE
Applicant:	Laurus
Ingredient:	abacavir sulfate; lamivudine
Patents:	0

Pharmacology for NDA: 216332

Mechanism of Action

Cytochrome P450 1A1 Inhibitors Nucleoside Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 216332

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ABACAVIR SULFATE AND LAMIVUDINE	abacavir sulfate; lamivudine	TABLET;ORAL	216332	ANDA	Laurus Labs Limited	42385-962	42385-962-18	180 TABLET, FILM COATED in 1 BOTTLE (42385-962-18)
ABACAVIR SULFATE AND LAMIVUDINE	abacavir sulfate; lamivudine	TABLET;ORAL	216332	ANDA	Laurus Labs Limited	42385-962	42385-962-30	30 TABLET, FILM COATED in 1 BOTTLE (42385-962-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 600MG BASE;300MG
Approval Date:	Jul 25, 2022	TE:	AB	RLD:	No

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