Last Updated: May 11, 2026

Details for New Drug Application (NDA): 078545

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NDA 078545 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, Natco, Pharmobedient, Somerset Theraps Llc, Strides Pharma, Chartwell Rx, Epic Pharma Llc, 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 078545

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

Medical Subject Heading (MeSH) Categories for 078545

Anti-HIV Agents
Reverse Transcriptase Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	150MG
Approval Date:	Mar 5, 2019	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Mar 5, 2019	TE:		RLD:	No

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