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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 090457


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NDA 090457 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, Mylan Labs Ltd, Strides Pharma, Upsher Smith Labs, Anda Repository, Chartwell Rx, 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 090457
Tradename:LAMIVUDINE
Applicant:Strides Pharma
Ingredient:lamivudine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090457
Medical Subject Heading (MeSH) Categories for 090457
Suppliers and Packaging for NDA: 090457
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LAMIVUDINE lamivudine TABLET;ORAL 090457 ANDA Strides Pharma Science Limited 64380-710 64380-710-03 60 TABLET, FILM COATED in 1 BOTTLE (64380-710-03)
LAMIVUDINE lamivudine TABLET;ORAL 090457 ANDA Strides Pharma Science Limited 64380-711 64380-711-04 30 TABLET, FILM COATED in 1 BOTTLE (64380-711-04)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Apr 19, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Apr 19, 2018TE:ABRLD:No

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