Last Updated: September 24, 2026

Details for New Drug Application (NDA): 202941


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NDA 202941 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, Macleods Pharms, Natco, Pharmobedient, Somerset Theraps Llc, Strides Pharma, Chartwell Rx, Epic Pharma Llc, Lupin Ltd, 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 four drug master file entries for this compound. Additional details are available on the lamivudine; nevirapine; zidovudine profile page.
Summary for 202941
Tradename:LAMIVUDINE
Applicant:Apotex
Ingredient:lamivudine
Patents:0
Pharmacology for NDA: 202941
Mechanism of ActionNucleoside Reverse Transcriptase Inhibitors
Medical Subject Heading (MeSH) Categories for 202941
Anti-HIV Agents
Reverse Transcriptase Inhibitors
Suppliers and Packaging for NDA: 202941
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LAMIVUDINE lamivudine TABLET;ORAL 202941 ANDA Golden State Medical Supply, Inc. 51407-866 51407-866-60 60 TABLET, FILM COATED in 1 BOTTLE (51407-866-60)
LAMIVUDINE lamivudine TABLET;ORAL 202941 ANDA Apotex Corp. 60505-3250 60505-3250-6 60 TABLET, FILM COATED in 1 BOTTLE (60505-3250-6)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Jan 2, 2014TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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