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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214301
Company: REGCON HOLDINGS

Products on ANDA 214301

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LACOSAMIDE	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214301

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/07/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 214301

LACOSAMIDE

SOLUTION;INTRAVENOUS; 200MG/20ML (10MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LACOSAMIDE	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	218464	ACELLA
LACOSAMIDE	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	220268	ANTHEA PHARMA
LACOSAMIDE	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216670	APOTEX
LACOSAMIDE	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216335	ASPIRO
LACOSAMIDE	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	217718	DR REDDYS
LACOSAMIDE	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	214677	FRESENIUS KABI USA
LACOSAMIDE	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	215628	GLAND
LACOSAMIDE	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	217311	HAINAN POLY
LACOSAMIDE	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216806	HIKMA
LACOSAMIDE	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	215979	MSN
LACOSAMIDE	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	214301	REGCON HOLDINGS
LACOSAMIDE	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	214960	SOMERSET THERAPS LLC
LACOSAMIDE	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	218706	WESTMINSTER PHARMS
LACOSAMIDE	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	209465	ZYDUS PHARMS
VIMPAT	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	022254	UCB INC

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