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 eight 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. Twenty-nine 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. Twenty-nine 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: | 8 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 215727
| Mechanism of Action | Cytochrome P450 3A4 Inhibitors P-Glycoprotein Interactions |
Medical Subject Heading (MeSH) Categories for 215727
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: | ⤷ Try a Trial | Patent Expiration: | Dec 31, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A METHOD OF TREATING CARDIOVASCULAR DISEASE | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jan 22, 2035 | 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: | ⤷ Try a Trial | Patent Expiration: | Jan 22, 2035 | 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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