Details for New Drug Application (NDA): 210942
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The generic ingredient in GLOPERBA is colchicine. There are sixteen drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the colchicine profile page.
Summary for 210942
Tradename: | GLOPERBA |
Applicant: | Scilex Pharms |
Ingredient: | colchicine |
Patents: | 4 |
Suppliers and Packaging for NDA: 210942
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GLOPERBA | colchicine | SOLUTION;ORAL | 210942 | NDA | Scilex Pharmaceuticals Inc. | 69557-222 | 69557-222-01 | 1 BOTTLE in 1 CARTON (69557-222-01) / 150 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 0.6MG/5ML | ||||
Approval Date: | Jan 30, 2019 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Dec 20, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Nov 22, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | A METHOD OF PROPHYLACTIC TREATMENT OF GOUT FLARES IN ADULTS COMPRISES ADMINISTERING TO A PATIENT A LIQUID COLCHICINE ORAL SOLUTION | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Nov 22, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? |
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