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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215628
Company: GLAND PHARMA LTD

Products on ANDA 215628

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 215628

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/19/2022	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
03/28/2023	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 215628

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	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 PHARMA LTD
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	214301	INDOCO
LACOSAMIDE	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	215979	MSN
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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