Details for New Drug Application (NDA): 212157
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NDA 212157 describes ELYXYB, which is a drug marketed by Scilex Pharms and is included in one NDA. It is available from two suppliers. There are six patents protecting this drug. Additional details are available on the ELYXYB profile page.
The generic ingredient in ELYXYB is celecoxib. There are twenty-six drug master file entries for this compound. Sixty-five suppliers are listed for this compound. Additional details are available on the celecoxib profile page.
The generic ingredient in ELYXYB is celecoxib. There are twenty-six drug master file entries for this compound. Sixty-five suppliers are listed for this compound. Additional details are available on the celecoxib profile page.
Summary for 212157
| Tradename: | ELYXYB |
| Applicant: | Scilex Pharms |
| Ingredient: | celecoxib |
| Patents: | 6 |
Pharmacology for NDA: 212157
| Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 212157
Suppliers and Packaging for NDA: 212157
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ELYXYB | celecoxib | SOLUTION;ORAL | 212157 | NDA | BioDelivery Sciences International Inc | 59385-055 | 59385-055-06 | 6 BOTTLE in 1 CARTON (59385-055-06) / 4.8 mL in 1 BOTTLE (59385-055-01) |
| ELYXYB | celecoxib | SOLUTION;ORAL | 212157 | NDA | BioDelivery Sciences International Inc | 59385-055 | 59385-055-22 | 1 BOTTLE in 1 CARTON (59385-055-22) / 4.8 mL in 1 BOTTLE (59385-055-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 25MG/ML | ||||
| Approval Date: | May 5, 2020 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | May 27, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN ADULTS | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | May 27, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN ADULTS | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | May 27, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN ADULTS | ||||||||
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