Details for New Drug Application (NDA): 211306

NDA 211306 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 211306

Tradename:	LAMIVUDINE
Applicant:	Annora
Ingredient:	lamivudine
Patents:	0

Pharmacology for NDA: 211306

Mechanism of Action

Nucleoside Reverse Transcriptase Inhibitors

Medical Subject Heading (MeSH) Categories for 211306

Anti-HIV Agents

Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 211306

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LAMIVUDINE	lamivudine	TABLET;ORAL	211306	ANDA	Camber Pharmaceuticals, Inc.	31722-001	31722-001-02	20 BLISTER PACK in 1 CARTON (31722-001-02) / 10 TABLET, FILM COATED in 1 BLISTER PACK
LAMIVUDINE	lamivudine	TABLET;ORAL	211306	ANDA	Camber Pharmaceuticals, Inc.	31722-001	31722-001-60	60 TABLET, FILM COATED in 1 BOTTLE (31722-001-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Mar 21, 2019	TE:	AB	RLD:	No

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