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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216335
Company: ASPIRO

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LACOSAMIDE LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription AP 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
09/14/2022 ORIG-1 Approval STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/18/2023 SUPPL-1 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

LACOSAMIDE

SOLUTION;INTRAVENOUS; 200MG/20ML (10MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LACOSAMIDE LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 218464 ACELLA
LACOSAMIDE LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 216670 APOTEX
LACOSAMIDE LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 216335 ASPIRO
LACOSAMIDE LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 217718 DR REDDYS
LACOSAMIDE LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 214677 FRESENIUS KABI USA
LACOSAMIDE LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 215628 GLAND
LACOSAMIDE LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 220268 GLENMARK PHARMS
LACOSAMIDE LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 217311 HAINAN POLY
LACOSAMIDE LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 216806 HIKMA
LACOSAMIDE LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 215979 MSN
LACOSAMIDE LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 214301 REGCON HOLDINGS
LACOSAMIDE LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 214960 SOMERSET THERAPS LLC
LACOSAMIDE LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 218706 WESTMINSTER PHARMS
LACOSAMIDE LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 209465 ZYDUS PHARMS
VIMPAT LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 022254 UCB INC
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