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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209301
Company: HETERO LABS LTD III

Products on ANDA 209301

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LACOSAMIDE	LACOSAMIDE	10MG/ML	SOLUTION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209301

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/31/2022	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
06/23/2025	SUPPL-6	Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels		Label is not available on this site.
07/12/2023	SUPPL-1	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 209301

LACOSAMIDE

SOLUTION;ORAL; 10MG/ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LACOSAMIDE	LACOSAMIDE	10MG/ML	SOLUTION;ORAL	Prescription	No	AA	219699	AJENAT PHARMS
LACOSAMIDE	LACOSAMIDE	10MG/ML	SOLUTION;ORAL	Prescription	No	AA	214672	ALKEM LABS LTD
LACOSAMIDE	LACOSAMIDE	10MG/ML	SOLUTION;ORAL	Prescription	No	AA	209224	AUROBINDO PHARMA LTD
LACOSAMIDE	LACOSAMIDE	10MG/ML	SOLUTION;ORAL	Prescription	No	AA	215154	CHARTWELL RX
LACOSAMIDE	LACOSAMIDE	10MG/ML	SOLUTION;ORAL	Prescription	No	AA	209301	HETERO LABS LTD III
LACOSAMIDE	LACOSAMIDE	10MG/ML	SOLUTION;ORAL	Prescription	No	AA	216461	KANCHAN HLTHCARE
LACOSAMIDE	LACOSAMIDE	10MG/ML	SOLUTION;ORAL	Prescription	No	AA	215379	MSN
LACOSAMIDE	LACOSAMIDE	10MG/ML	SOLUTION;ORAL	Prescription	No	AA	216151	NOVITIUM PHARMA
LACOSAMIDE	LACOSAMIDE	10MG/ML	SOLUTION;ORAL	Prescription	No	AA	217596	PROD DEVELOPMENT
LACOSAMIDE	LACOSAMIDE	10MG/ML	SOLUTION;ORAL	Prescription	No	AA	220386	REGCON HOLDINGS
LACOSAMIDE	LACOSAMIDE	10MG/ML	SOLUTION;ORAL	Prescription	No	AA	220366	STERANCO HLTHCARE
VIMPAT	LACOSAMIDE	10MG/ML	SOLUTION;ORAL	Prescription	Yes	AA	022255	UCB INC

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