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Last Updated: June 12, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077464


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NDA 077464 describes LAMIVUDINE, which is a drug marketed by Aurobindo Pharma Ltd, Lannett Co Inc, Annora, Apotex, Arise, Cipla, Hetero Labs Ltd V, Lupin Ltd, Macleods Pharms Ltd, Mylan, Mylan Labs Ltd, Pharma Life, Strides Pharma, Anda Repository, Hetero Labs Ltd Iii, Pharmacare, Teva Pharms, and Micro Labs, and is included in thirty-three NDAs. It is available from sixteen 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 077464
Tradename:LAMIVUDINE
Applicant:Aurobindo Pharma Ltd
Ingredient:lamivudine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077464
Medical Subject Heading (MeSH) Categories for 077464
Suppliers and Packaging for NDA: 077464
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LAMIVUDINE lamivudine TABLET;ORAL 077464 ANDA American Health Packaging 60687-362 60687-362-21 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-362-21) > 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-362-11)
LAMIVUDINE lamivudine TABLET;ORAL 077464 ANDA Aurobindo Pharma Limited 65862-025 65862-025-10 6 BLISTER PACK in 1 CARTON (65862-025-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK

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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