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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205031
Company: SUN PHARM
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
03/17/2022 ORIG-1 Approval STANDARD

Label is not available on this site.

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 205011 ACCORD HLTHCARE
LACOSAMIDE LACOSAMIDE 50MG TABLET;ORAL Prescription No AB 204974 ALEMBIC PHARMS LTD
LACOSAMIDE LACOSAMIDE 50MG TABLET;ORAL Prescription No AB 214695 ALKEM LABS LTD
LACOSAMIDE LACOSAMIDE 50MG TABLET;ORAL Prescription No AB 204857 AMNEAL PHARMS
LACOSAMIDE LACOSAMIDE 50MG TABLET;ORAL Prescription No AB 214567 APOTEX
LACOSAMIDE LACOSAMIDE 50MG TABLET;ORAL Prescription No AB 205006 GLENMARK PHARMS LTD
LACOSAMIDE LACOSAMIDE 50MG TABLET;ORAL Prescription No AB 204787 HETERO LABS LTD V
LACOSAMIDE LACOSAMIDE 50MG TABLET;ORAL Prescription No AB 208308 INDOCO
LACOSAMIDE LACOSAMIDE 50MG TABLET;ORAL Prescription No AB 204921 MSN LABS PVT LTD
LACOSAMIDE LACOSAMIDE 50MG TABLET;ORAL Prescription No AB 205237 SCIEGEN PHARMS INC
LACOSAMIDE LACOSAMIDE 50MG TABLET;ORAL Prescription No AB 205031 SUN PHARM
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 205011 ACCORD HLTHCARE
LACOSAMIDE LACOSAMIDE 100MG TABLET;ORAL Prescription No AB 204974 ALEMBIC PHARMS LTD
LACOSAMIDE LACOSAMIDE 100MG TABLET;ORAL Prescription No AB 214695 ALKEM LABS LTD
LACOSAMIDE LACOSAMIDE 100MG TABLET;ORAL Prescription No AB 204857 AMNEAL PHARMS
LACOSAMIDE LACOSAMIDE 100MG TABLET;ORAL Prescription No AB 214567 APOTEX
LACOSAMIDE LACOSAMIDE 100MG TABLET;ORAL Prescription No AB 205006 GLENMARK PHARMS LTD
LACOSAMIDE LACOSAMIDE 100MG TABLET;ORAL Prescription No AB 204787 HETERO LABS LTD V
LACOSAMIDE LACOSAMIDE 100MG TABLET;ORAL Prescription No AB 208308 INDOCO
LACOSAMIDE LACOSAMIDE 100MG TABLET;ORAL Prescription No AB 204921 MSN LABS PVT LTD
LACOSAMIDE LACOSAMIDE 100MG TABLET;ORAL Prescription No AB 205237 SCIEGEN PHARMS INC
LACOSAMIDE LACOSAMIDE 100MG TABLET;ORAL Prescription No AB 205031 SUN PHARM
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 205011 ACCORD HLTHCARE
LACOSAMIDE LACOSAMIDE 150MG TABLET;ORAL Prescription No AB 204974 ALEMBIC PHARMS LTD
LACOSAMIDE LACOSAMIDE 150MG TABLET;ORAL Prescription No AB 214695 ALKEM LABS LTD
LACOSAMIDE LACOSAMIDE 150MG TABLET;ORAL Prescription No AB 204857 AMNEAL PHARMS
LACOSAMIDE LACOSAMIDE 150MG TABLET;ORAL Prescription No AB 214567 APOTEX
LACOSAMIDE LACOSAMIDE 150MG TABLET;ORAL Prescription No AB 205006 GLENMARK PHARMS LTD
LACOSAMIDE LACOSAMIDE 150MG TABLET;ORAL Prescription No AB 204787 HETERO LABS LTD V
LACOSAMIDE LACOSAMIDE 150MG TABLET;ORAL Prescription No AB 208308 INDOCO
LACOSAMIDE LACOSAMIDE 150MG TABLET;ORAL Prescription No AB 204921 MSN LABS PVT LTD
LACOSAMIDE LACOSAMIDE 150MG TABLET;ORAL Prescription No AB 205237 SCIEGEN PHARMS INC
LACOSAMIDE LACOSAMIDE 150MG TABLET;ORAL Prescription No AB 205031 SUN PHARM
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 205011 ACCORD HLTHCARE
LACOSAMIDE LACOSAMIDE 200MG TABLET;ORAL Prescription No AB 204974 ALEMBIC PHARMS LTD
LACOSAMIDE LACOSAMIDE 200MG TABLET;ORAL Prescription No AB 214695 ALKEM LABS LTD
LACOSAMIDE LACOSAMIDE 200MG TABLET;ORAL Prescription No AB 204857 AMNEAL PHARMS
LACOSAMIDE LACOSAMIDE 200MG TABLET;ORAL Prescription No AB 214567 APOTEX
LACOSAMIDE LACOSAMIDE 200MG TABLET;ORAL Prescription No AB 205006 GLENMARK PHARMS LTD
LACOSAMIDE LACOSAMIDE 200MG TABLET;ORAL Prescription No AB 204787 HETERO LABS LTD V
LACOSAMIDE LACOSAMIDE 200MG TABLET;ORAL Prescription No AB 208308 INDOCO
LACOSAMIDE LACOSAMIDE 200MG TABLET;ORAL Prescription No AB 204921 MSN LABS PVT LTD
LACOSAMIDE LACOSAMIDE 200MG TABLET;ORAL Prescription No AB 205237 SCIEGEN PHARMS INC
LACOSAMIDE LACOSAMIDE 200MG TABLET;ORAL Prescription No AB 205031 SUN PHARM
VIMPAT LACOSAMIDE 200MG TABLET;ORAL Prescription Yes AB 022253 UCB INC
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