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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 206974


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NDA 206974 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 twelve 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 206974
Tradename:LAMIVUDINE
Applicant:Appco
Ingredient:lamivudine
Patents:0
Pharmacology for NDA: 206974
Mechanism of ActionNucleoside Reverse Transcriptase Inhibitors
Medical Subject Heading (MeSH) Categories for 206974
Anti-HIV Agents
Reverse Transcriptase Inhibitors
Suppliers and Packaging for NDA: 206974
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LAMIVUDINE lamivudine TABLET;ORAL 206974 ANDA Ingenus Pharmaceuticals, LLC 50742-623 50742-623-60 60 TABLET in 1 BOTTLE, PLASTIC (50742-623-60)
LAMIVUDINE lamivudine TABLET;ORAL 206974 ANDA Ingenus Pharmaceuticals, LLC 50742-624 50742-624-60 30 TABLET in 1 BOTTLE, PLASTIC (50742-624-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Nov 21, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Nov 21, 2016TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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