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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022225
Company: MSD SUB MERCK

Summary Review

Products on NDA 022225

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BRIDION	SUGAMMADEX SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	Yes	Yes
BRIDION	SUGAMMADEX SODIUM	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022225

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/15/2015	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022225lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022225Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022225Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022225Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/17/2022	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022225Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022225Orig1s012ltr.pdf
01/22/2021	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022225s007s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022225Orig1s007, s009ltr.pdf
06/25/2021	SUPPL-8	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022225s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022225Orig1s008ltr.pdf
01/22/2021	SUPPL-7	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022225s007s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022225Orig1s007, s009ltr.pdf
06/09/2020	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022225s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022225Orig1s006ltr.pdf
10/24/2016	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022225s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022225Orig1s001ltr.pdf

Labels for NDA 022225

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/17/2022	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022225Orig1s012lbl.pdf
06/25/2021	SUPPL-8	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022225s008lbl.pdf
01/22/2021	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022225s007s009lbl.pdf
01/22/2021	SUPPL-7	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022225s007s009lbl.pdf
06/09/2020	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022225s006lbl.pdf
10/24/2016	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022225s001lbl.pdf
12/15/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022225lbl.pdf

Therapeutic Equivalents for NDA 022225

BRIDION

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

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

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