Details for New Drug Application (NDA): 090198

NDA 090198 describes LAMIVUDINE, which is a drug marketed by Aurobindo Pharma, Chartwell Molecular, Hetero Labs Ltd Iii, Annora, Apotex, Aurobindo Pharma Ltd, Aurobindo Pharma Usa, Breckenridge, Cipla, Hetero Labs Ltd V, Lupin Ltd, Macleods Pharms Ltd, Mylan Labs Ltd, Natco, Strides Pharma, Upsher Smith Labs, Chartwell Rx, Epic Pharma Llc, Norvium Bioscience, Pharmacare, and Micro Labs, and is included in thirty-four NDAs. It is available from thirteen suppliers. Additional details are available on the LAMIVUDINE profile page.

The generic ingredient in LAMIVUDINE is lamivudine; nevirapine; zidovudine. There are twenty-nine drug master file entries for this compound. Additional details are available on the lamivudine; nevirapine; zidovudine profile page.

Summary for 090198

Tradename:	LAMIVUDINE
Applicant:	Macleods Pharms Ltd
Ingredient:	lamivudine
Patents:	0

Pharmacology for NDA: 090198

Mechanism of Action

Nucleoside Reverse Transcriptase Inhibitors

Medical Subject Heading (MeSH) Categories for 090198

Anti-HIV Agents

Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 090198

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LAMIVUDINE	lamivudine	TABLET;ORAL	090198	ANDA	Macleods Pharmaceuticals Limited	33342-001	33342-001-09	60 TABLET, FILM COATED in 1 BOTTLE (33342-001-09)
LAMIVUDINE	lamivudine	TABLET;ORAL	090198	ANDA	Macleods Pharmaceuticals Limited	33342-002	33342-002-07	30 TABLET, FILM COATED in 1 BOTTLE (33342-002-07)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	150MG
Approval Date:	May 1, 2019	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	May 1, 2019	TE:	AB	RLD:	No

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