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Last Updated: January 29, 2026

Details for New Drug Application (NDA): 091475

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NDA 091475 describes LAMIVUDINE, which is a drug marketed by Aurobindo Pharma, Chartwell Molecular, Hetero Labs Ltd Iii, Annora, Apotex, Appco, Aurobindo Pharma Ltd, Aurobindo Pharma Usa, Breckenridge, Cipla, Hetero Labs Ltd V, Lupin Ltd, Macleods Pharms Ltd, Natco, Pharmobedient, Strides Pharma, 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 091475

Tradename:	LAMIVUDINE
Applicant:	Hetero Labs Ltd Iii
Ingredient:	lamivudine
Patents:	0

Medical Subject Heading (MeSH) Categories for 091475

Anti-HIV Agents
Reverse Transcriptase Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	10MG/ML
Approval Date:	Oct 6, 2023	TE:	AA	RLD:	No

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