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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 204994


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NDA 204994 describes LACOSAMIDE, which is a drug marketed by Apotex, Aspiro, Fresenius Kabi Usa, Gland Pharma Ltd, Indoco, MSN, Zydus Pharms, Alkem Labs Ltd, Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, Leading Pharma, Novitium Pharma, Accord Hlthcare, Actavis Labs Fl Inc, Alembic, Amneal Pharms, Glenmark Pharms Ltd, Hetero Labs Ltd V, Msn Labs Pvt Ltd, Sciegen Pharms Inc, and Sun Pharm, and is included in twenty-eight NDAs. It is available from thirty-six suppliers. Additional details are available on the LACOSAMIDE profile page.

The generic ingredient in LACOSAMIDE is lacosamide. There are twenty-two drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the lacosamide profile page.
Summary for 204994
Tradename:LACOSAMIDE
Applicant:Aurobindo Pharma Ltd
Ingredient:lacosamide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204994
Suppliers and Packaging for NDA: 204994
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LACOSAMIDE lacosamide TABLET;ORAL 204994 ANDA Aurobindo Pharma Limited 65862-747 65862-747-03 3 BLISTER PACK in 1 CARTON (65862-747-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-747-10)
LACOSAMIDE lacosamide TABLET;ORAL 204994 ANDA Aurobindo Pharma Limited 65862-747 65862-747-60 60 TABLET, FILM COATED in 1 BOTTLE (65862-747-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jan 5, 2023TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Jan 5, 2023TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Jan 5, 2023TE:ABRLD:No

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