➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Express Scripts

Last Updated: June 12, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077464

Email this page to a colleague

« Back to Dashboard

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
Applicant:Aurobindo Pharma Ltd
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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.