Details for New Drug Application (NDA): 210942
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NDA 210942 describes GLOPERBA, which is a drug marketed by Scilex Pharms and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the GLOPERBA profile page.
The generic ingredient in GLOPERBA is colchicine. There are sixteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the colchicine profile page.
The generic ingredient in GLOPERBA is colchicine. There are sixteen drug master file entries for this compound. Twenty-nine 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 |
| Formulation / Manufacturing: | see details |
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: | ⤷ Try a Trial | Patent Expiration: | Dec 20, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | 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: | ⤷ Try a Trial | Patent Expiration: | Nov 22, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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