Details for New Drug Application (NDA): 022225
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The generic ingredient in BRIDION is sugammadex sodium. There is one drug master file entry for this compound. Twenty-four 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: | Dec 12, 2027 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Regulatory Exclusivity Expiration: | Jun 12, 2028 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Patent: | RE44733*PED | Patent Expiration: | Jul 27, 2026 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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 | 6,949,527 | ⤷ Start Trial |
| Msd Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-002 | Dec 15, 2015 | 6,949,527 | ⤷ Start Trial |
| Msd Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-002 | Dec 15, 2015 | 7,265,099 | ⤷ Start Trial |
| Msd Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-001 | Dec 15, 2015 | 7,265,009 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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