An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 205006
Company: GLENMARK PHARMS LTD

Products on ANDA 205006

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 205006

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/2015/205006Orig1s000TAltr.pdf

Therapeutic Equivalents for ANDA 205006

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	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	KANCHAN HLTHCARE
LACOSAMIDE	LACOSAMIDE	50MG	TABLET;ORAL	Prescription	No	AB	208466	MACLEODS PHARMS LTD
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	213109	UNICHEM
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	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	KANCHAN HLTHCARE
LACOSAMIDE	LACOSAMIDE	100MG	TABLET;ORAL	Prescription	No	AB	208466	MACLEODS PHARMS LTD
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	213109	UNICHEM
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	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	KANCHAN HLTHCARE
LACOSAMIDE	LACOSAMIDE	150MG	TABLET;ORAL	Prescription	No	AB	208466	MACLEODS PHARMS LTD
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	213109	UNICHEM
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	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	KANCHAN HLTHCARE
LACOSAMIDE	LACOSAMIDE	200MG	TABLET;ORAL	Prescription	No	AB	208466	MACLEODS PHARMS LTD
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	213109	UNICHEM
VIMPAT	LACOSAMIDE	200MG	TABLET;ORAL	Prescription	Yes	AB	022253	UCB INC

Top