Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 204839
Company: AMNEAL PHARMS
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
04/28/2016 ORIG-1 Approval STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204839s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204839Orig1s000ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/28/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204839s000lbl.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 204839 AMNEAL PHARMS
VIMPAT LACOSAMIDE 10MG/ML SOLUTION;ORAL Prescription Yes AA 022255 UCB INC

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