U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 214672
Company: ALKEM LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LACOSAMIDE LACOSAMIDE 10MG/ML SOLUTION;ORAL Prescription AA No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/19/2022 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214672Orig1s000ltr.pdf

LACOSAMIDE

SOLUTION;ORAL; 10MG/ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LACOSAMIDE LACOSAMIDE 10MG/ML SOLUTION;ORAL Prescription No AA 214672 ALKEM LABS LTD
LACOSAMIDE LACOSAMIDE 10MG/ML SOLUTION;ORAL Prescription No AA 206355 APOTEX
LACOSAMIDE LACOSAMIDE 10MG/ML SOLUTION;ORAL Prescription No AA 209301 HETERO LABS LTD III
LACOSAMIDE LACOSAMIDE 10MG/ML SOLUTION;ORAL Prescription No AA 216151 NOVITIUM PHARMA
VIMPAT LACOSAMIDE 10MG/ML SOLUTION;ORAL Prescription Yes AA 022255 UCB INC
Back to Top