You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: June 23, 2024

Details for New Drug Application (NDA): 216461

✉ Email this page to a colleague

« Back to Dashboard

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
Applicant:Leading Pharma
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

Complete Access Available with Subscription

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

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.