Details for New Drug Application (NDA): 215444
✉ Email this page to a colleague
The generic ingredient in COLCHICINE is colchicine. There are sixteen drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the colchicine profile page.
Summary for 215444
Tradename: | COLCHICINE |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | colchicine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 215444
Mechanism of Action | Cytochrome P450 3A4 Inhibitors P-Glycoprotein Interactions |
Medical Subject Heading (MeSH) Categories for 215444
Suppliers and Packaging for NDA: 215444
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
COLCHICINE | colchicine | TABLET;ORAL | 215444 | ANDA | Aurobindo Pharma Limited | 59651-455 | 59651-455-01 | 100 TABLET in 1 BOTTLE (59651-455-01) |
COLCHICINE | colchicine | TABLET;ORAL | 215444 | ANDA | Aurobindo Pharma Limited | 59651-455 | 59651-455-30 | 30 TABLET in 1 BOTTLE (59651-455-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.6MG | ||||
Approval Date: | Jan 6, 2022 | TE: | AB | RLD: | No |
Complete Access Available with Subscription