Details for New Drug Application (NDA): 022225
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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 |
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: | ⤷ Sign Up | 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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Msd Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-001 | Dec 15, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Msd Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-001 | Dec 15, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Msd Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-002 | Dec 15, 2015 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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