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Generated: April 23, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206974

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NDA 206974 describes LAMIVUDINE, which is a drug marketed by Aurobindo Pharma Ltd, Lannett Co Inc, Apotex, Apotex Inc, Arise Pharms, Cipla, Eci Pharms Llc, Hetero Labs Ltd V, Lupin Ltd, Mylan Labs Ltd, Mylan Pharms Inc, Strides Pharma, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Pharmacare, Shanghai Desano, Teva Pharms, and Micro Labs, and is included in thirty NDAs. It is available from twenty 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. One supplier is listed for this compound. Additional details are available on the lamivudine; nevirapine; zidovudine profile page.
Summary for 206974
Applicant:Arise Pharms
Formulation / Manufacturing:see details
Pharmacology for NDA: 206974
Medical Subject Heading (MeSH) Categories for 206974
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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