Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214279
Company: B BRAUN MEDICAL

Products on ANDA 214279

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SUGAMMADEX SODIUM	SUGAMMADEX SODIUM	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214279

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/05/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 214279

SUGAMMADEX SODIUM

SOLUTION;INTRAVENOUS; EQ 200MG BASE/2ML (EQ 100MG BASE/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BRIDION	SUGAMMADEX SODIUM	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	022225	MSD SUB MERCK
SUGAMMADEX SODIUM	SUGAMMADEX SODIUM	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	214337	ASPIRO
SUGAMMADEX SODIUM	SUGAMMADEX SODIUM	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	214279	B BRAUN MEDICAL
SUGAMMADEX SODIUM	SUGAMMADEX SODIUM	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	214290	ZYDUS PHARMS