Details for New Drug Application (NDA): 022225

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NDA 022225 describes BRIDION, which is a drug marketed by Msd Sub Merck and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the BRIDION profile page.

The generic ingredient in BRIDION is sugammadex sodium. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the sugammadex sodium profile page.

Summary for 022225

Tradename:	BRIDION
Applicant:	Msd Sub Merck
Ingredient:	sugammadex sodium
Patents:	1

Pharmacology for NDA: 022225

Suppliers and Packaging for NDA: 022225

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225	NDA	Merck Sharp & Dohme LLC	0006-5423	0006-5423-12	10 VIAL, SINGLE-DOSE in 1 CARTON (0006-5423-12) / 2 mL in 1 VIAL, SINGLE-DOSE (0006-5423-02)
BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225	NDA	Merck Sharp & Dohme LLC	0006-5423	0006-5423-15	10 VIAL, SINGLE-DOSE in 1 CARTON (0006-5423-15) / 5 mL in 1 VIAL, SINGLE-DOSE (0006-5423-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)
Approval Date:	Dec 15, 2015	TE:	AP	RLD:	Yes
Regulatory Exclusivity Expiration:	Jun 25, 2024
Regulatory Exclusivity Use:	NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:	Jan 22, 2024
Regulatory Exclusivity Use:	REVISIONS TO THE USE IN SPECIFIC POPULATIONS SECTION OF THE PACKAGE INSERT TO INCLUDE THE RESULT OF STUDY P145
Patent:	RE44733	Patent Expiration:	Jan 27, 2026	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	REVERSAL OF DRUG-INDUCED NEUROMUSCULAR BLOCK

Expired US Patents for NDA 022225

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-002	Dec 15, 2015	6,949,527	⤷ Subscribe
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-001	Dec 15, 2015	7,265,009	⤷ Subscribe
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-001	Dec 15, 2015	6,949,527	⤷ Subscribe
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-001	Dec 15, 2015	7,265,099	⤷ Subscribe
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