Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214337
Company: ASPIRO

Products on ANDA 214337

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
SUGAMMADEX SODIUM	SUGAMMADEX SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214337

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/09/2023	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214337Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/08/2024	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 214337

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

SOLUTION;INTRAVENOUS; EQ 500MG BASE/5ML (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 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	022225	MSD SUB MERCK
SUGAMMADEX SODIUM	SUGAMMADEX SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	214337	ASPIRO