Details for New Drug Application (NDA): 212157
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The generic ingredient in ELYXYB is celecoxib. There are twenty-six drug master file entries for this compound. Sixty-four 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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