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. Three 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: | ⤷ Get Started Free | 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 | ⤷ Get Started Free | ⤷ Get Started Free |
| Msd Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-002 | Dec 15, 2015 | ⤷ Get Started Free | ⤷ Get Started Free |
| Msd Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-001 | Dec 15, 2015 | ⤷ Get Started Free | ⤷ Get Started Free |
| Msd Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-002 | Dec 15, 2015 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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