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Last Updated: June 23, 2024

Details for New Drug Application (NDA): 216461


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NDA 216461 describes LACOSAMIDE, which is a drug marketed by Apotex, Aspiro, Dr Reddys, Fresenius Kabi Usa, Gland Pharma Ltd, Hainan Poly, Hikma, Indoco, MSN, Zydus Pharms, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, Leading Pharma, Novitium Pharma, Accord Hlthcare, Actavis Labs Fl Inc, Alembic, Glenmark Pharms Ltd, Hetero Labs Ltd V, Medley Pharms, Msn Labs Pvt Ltd, Sciegen Pharms Inc, and Sun Pharm, and is included in thirty-three NDAs. It is available from forty-two 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. Forty-four suppliers are listed for this compound. Additional details are available on the lacosamide profile page.
Summary for 216461
Tradename:LACOSAMIDE
Applicant:Leading Pharma
Ingredient:lacosamide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 216461
Suppliers and Packaging for NDA: 216461
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LACOSAMIDE lacosamide SOLUTION;ORAL 216461 ANDA Leading Pharma, LLC 69315-318 69315-318-20 200 mL in 1 BOTTLE, PLASTIC (69315-318-20)
LACOSAMIDE lacosamide SOLUTION;ORAL 216461 ANDA Leading Pharma, LLC 69315-318 69315-318-46 465 mL in 1 BOTTLE, PLASTIC (69315-318-46)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength10MG/ML
Approval Date:Feb 6, 2023TE:AARLD:No

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