Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 204974
Company: ALEMBIC PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LACOSAMIDE LACOSAMIDE 50MG TABLET;ORAL Prescription AB No No
LACOSAMIDE LACOSAMIDE 100MG TABLET;ORAL Prescription AB No No
LACOSAMIDE LACOSAMIDE 150MG TABLET;ORAL Prescription AB No No
LACOSAMIDE LACOSAMIDE 200MG TABLET;ORAL Prescription AB 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)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204974Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204974Orig1s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204974Orig1s000ltr.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/2016/204974Orig1s000lbl.pdf

LACOSAMIDE

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LACOSAMIDE LACOSAMIDE 50MG TABLET;ORAL Prescription No AB 204855 ACTAVIS LABS FL INC
LACOSAMIDE LACOSAMIDE 50MG TABLET;ORAL Prescription No AB 204974 ALEMBIC PHARMS LTD
LACOSAMIDE LACOSAMIDE 50MG TABLET;ORAL Prescription No AB 204857 AMNEAL PHARMS
LACOSAMIDE LACOSAMIDE 50MG TABLET;ORAL Prescription No AB 204994 AUROBINDO PHARMA LTD
LACOSAMIDE LACOSAMIDE 50MG TABLET;ORAL Prescription No AB 204921 MSN LABS PVT LTD
LACOSAMIDE LACOSAMIDE 50MG TABLET;ORAL Prescription No AB 205026 MYLAN PHARMS INC
LACOSAMIDE LACOSAMIDE 50MG TABLET;ORAL Prescription No AB 205031 SUN PHARMA GLOBAL
VIMPAT LACOSAMIDE 50MG TABLET;ORAL Prescription Yes AB 022253 UCB INC

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LACOSAMIDE LACOSAMIDE 100MG TABLET;ORAL Prescription No AB 204855 ACTAVIS LABS FL INC
LACOSAMIDE LACOSAMIDE 100MG TABLET;ORAL Prescription No AB 204974 ALEMBIC PHARMS LTD
LACOSAMIDE LACOSAMIDE 100MG TABLET;ORAL Prescription No AB 204857 AMNEAL PHARMS
LACOSAMIDE LACOSAMIDE 100MG TABLET;ORAL Prescription No AB 204994 AUROBINDO PHARMA LTD
LACOSAMIDE LACOSAMIDE 100MG TABLET;ORAL Prescription No AB 204921 MSN LABS PVT LTD
LACOSAMIDE LACOSAMIDE 100MG TABLET;ORAL Prescription No AB 205026 MYLAN PHARMS INC
LACOSAMIDE LACOSAMIDE 100MG TABLET;ORAL Prescription No AB 205031 SUN PHARMA GLOBAL
VIMPAT LACOSAMIDE 100MG TABLET;ORAL Prescription Yes AB 022253 UCB INC

TABLET;ORAL; 150MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LACOSAMIDE LACOSAMIDE 150MG TABLET;ORAL Prescription No AB 204855 ACTAVIS LABS FL INC
LACOSAMIDE LACOSAMIDE 150MG TABLET;ORAL Prescription No AB 204974 ALEMBIC PHARMS LTD
LACOSAMIDE LACOSAMIDE 150MG TABLET;ORAL Prescription No AB 204857 AMNEAL PHARMS
LACOSAMIDE LACOSAMIDE 150MG TABLET;ORAL Prescription No AB 204994 AUROBINDO PHARMA LTD
LACOSAMIDE LACOSAMIDE 150MG TABLET;ORAL Prescription No AB 204921 MSN LABS PVT LTD
LACOSAMIDE LACOSAMIDE 150MG TABLET;ORAL Prescription No AB 205026 MYLAN PHARMS INC
LACOSAMIDE LACOSAMIDE 150MG TABLET;ORAL Prescription No AB 205031 SUN PHARMA GLOBAL
VIMPAT LACOSAMIDE 150MG TABLET;ORAL Prescription Yes AB 022253 UCB INC

TABLET;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LACOSAMIDE LACOSAMIDE 200MG TABLET;ORAL Prescription No AB 204855 ACTAVIS LABS FL INC
LACOSAMIDE LACOSAMIDE 200MG TABLET;ORAL Prescription No AB 204974 ALEMBIC PHARMS LTD
LACOSAMIDE LACOSAMIDE 200MG TABLET;ORAL Prescription No AB 204857 AMNEAL PHARMS
LACOSAMIDE LACOSAMIDE 200MG TABLET;ORAL Prescription No AB 204994 AUROBINDO PHARMA LTD
LACOSAMIDE LACOSAMIDE 200MG TABLET;ORAL Prescription No AB 204921 MSN LABS PVT LTD
LACOSAMIDE LACOSAMIDE 200MG TABLET;ORAL Prescription No AB 205026 MYLAN PHARMS INC
LACOSAMIDE LACOSAMIDE 200MG TABLET;ORAL Prescription No AB 205031 SUN PHARMA GLOBAL
VIMPAT LACOSAMIDE 200MG TABLET;ORAL Prescription Yes AB 022253 UCB INC

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English