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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204921
Company: MSN LABS PVT LTD

Products on ANDA 204921

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204921

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	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204921Orig1s000TA_ltr.pdf

Therapeutic Equivalents for ANDA 204921

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	204974	ALEMBIC
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	204994	AUROBINDO PHARMA LTD
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	218014	MEDLEY PHARMS
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
LACOSAMIDE	LACOSAMIDE	50MG	TABLET;ORAL	Prescription	No	AB	204947	ZYDUS PHARMS
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	204974	ALEMBIC
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	204994	AUROBINDO PHARMA LTD
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	218014	MEDLEY PHARMS
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
LACOSAMIDE	LACOSAMIDE	100MG	TABLET;ORAL	Prescription	No	AB	204947	ZYDUS PHARMS
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	204974	ALEMBIC
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	204994	AUROBINDO PHARMA LTD
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	218014	MEDLEY PHARMS
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
LACOSAMIDE	LACOSAMIDE	150MG	TABLET;ORAL	Prescription	No	AB	204947	ZYDUS PHARMS
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	204974	ALEMBIC
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	204994	AUROBINDO PHARMA LTD
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	218014	MEDLEY PHARMS
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
LACOSAMIDE	LACOSAMIDE	200MG	TABLET;ORAL	Prescription	No	AB	204947	ZYDUS PHARMS
VIMPAT	LACOSAMIDE	200MG	TABLET;ORAL	Prescription	Yes	AB	022253	UCB INC

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