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Last Updated: April 21, 2024

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
Formulation / Manufacturing:see details
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:RXDosage:SOLUTION;INTRAVENOUSStrengthEQ 500MG BASE/5ML (EQ 100MG BASE/ML)
Approval Date:Dec 15, 2015TE:APRLD: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:⤷  Try a TrialPatent Expiration:Jan 27, 2026Product Flag?YSubstance Flag?YDelist Request?
Patented Use:REVERSAL OF DRUG-INDUCED NEUROMUSCULAR BLOCK

Expired US Patents for NDA 022225

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 ⤷  Try a Trial ⤷  Try a Trial
Msd Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-002 Dec 15, 2015 ⤷  Try a Trial ⤷  Try a Trial
Msd Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-001 Dec 15, 2015 ⤷  Try a Trial ⤷  Try a Trial
Msd Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-001 Dec 15, 2015 ⤷  Try a Trial ⤷  Try a Trial
Msd Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-002 Dec 15, 2015 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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