Details for New Drug Application (NDA): 215727
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NDA 215727 describes LODOCO, which is a drug marketed by Agepha Pharma Fz and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the LODOCO profile page.
The generic ingredient in LODOCO 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.
The generic ingredient in LODOCO 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 215727
| Tradename: | LODOCO |
| Applicant: | Agepha Pharma Fz |
| Ingredient: | colchicine |
| Patents: | 10 |
Suppliers and Packaging for NDA: 215727
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LODOCO | colchicine | TABLET;ORAL | 215727 | NDA | AGEPHA Pharma USA, LLC | 82867-001 | 82867-001-01 | 1 BLISTER PACK in 1 CARTON (82867-001-01) / 30 TABLET in 1 BLISTER PACK |
| LODOCO | colchicine | TABLET;ORAL | 215727 | NDA | AGEPHA Pharma USA, LLC | 82867-001 | 82867-001-02 | 1 BLISTER PACK in 1 CARTON (82867-001-02) / 30 TABLET in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
| Approval Date: | Jun 16, 2023 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | May 9, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A METHOD OF TREATING CARDIOVASCULAR DISEASE | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Nov 1, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A METHOD OF TREATING AND/OR REDUCING THE RISK OF A CARDIOVASCULAR EVENT; ACUTE CORONARY SYNDROME, OUT-OF-HOSPITAL CARDIAC ARREST, AND/OR NONCARDIOEMBOLIC ISCHEMIC STROKE | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Nov 1, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A METHOD FOR TREATING AND/OR REDUCING THE RISK OF A CARDIOVASCULAR EVENT | ||||||||
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