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Details for New Drug Application (NDA): 022225
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. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the sugammadex sodium profile page.
The generic ingredient in BRIDION is sugammadex sodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the sugammadex sodium profile page.
Summary for 022225
| Tradename: | BRIDION |
| Applicant: | Organon Sub Merck |
| Ingredient: | sugammadex sodium |
| Patents: | 3 |
Pharmacology for NDA: 022225
| Ingredient-type | gamma-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 | N | 0006-5423-12 |
| BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225 | NDA | Merck Sharp & Dohme Corp. | 0006-5423 | N | 0006-5423-15 |
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: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 15, 2020 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ➤ Try a Free Trial | Patent Expiration: | Jan 27, 2021 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | REVERSAL OF NEUROMUSCULAR BLOCKAGE INDUCED BY ROCURONIUM BROMIDE OR VECURONIUM BROMIDE | ||||||||
| Patent: | ➤ Try a Free Trial | Patent Expiration: | Aug 7, 2020 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | REVERSAL OF NEUROMUSCULAR BLOCKAGE INDUCED BY ROCURONIUM BROMIDE OR VECURONIUM BROMIDE | ||||||||
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