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Details for New Drug Application (NDA): 022225

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NDA 022225 describes BRIDION, which is a drug marketed by Organon Sub Merck and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the BRIDION profile page.

The generic ingredient in BRIDION is sugammadex sodium. One supplier is listed for this compound. Additional details are available on the sugammadex sodium profile page.

Summary for NDA: 022225

Tradename:
BRIDION
Applicant:
Organon Sub Merck
Ingredient:
sugammadex sodium
Patents:3

Pharmacology for NDA: 022225

Ingredient-typegamma-Cyclodextrins

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 Corp. 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 Corp. 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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrengthEQ 500MG BASE/5ML (EQ 100MG BASE/ML)
Approval Date:Dec 15, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 15, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:RE44733Patent Expiration:Jan 27, 2021Product Flag?YSubstance Flag?YDelist Request?
Patented Use:REVERSAL OF DRUG-INDUCED NEUROMUSCLUAR BLOCK
Patent:6,949,527Patent Expiration:Jan 27, 2021Product Flag?Substance Flag?Delist Request?
Patented Use:REVERSAL OF NEUROMUSCLUAR BLOCKAGE INDUCED BY ROCURONIUM BROMIDE OR VECURONIUM BROMIDE


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