Details for New Drug Application (NDA): 211250
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The generic ingredient in COLCHICINE 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 211250
Tradename: | COLCHICINE |
Applicant: | Alkem Labs Ltd |
Ingredient: | colchicine |
Patents: | 0 |
Pharmacology for NDA: 211250
Mechanism of Action | Cytochrome P450 3A4 Inhibitors P-Glycoprotein Interactions |
Medical Subject Heading (MeSH) Categories for 211250
Suppliers and Packaging for NDA: 211250
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
COLCHICINE | colchicine | TABLET;ORAL | 211250 | ANDA | Bryant Ranch Prepack | 63629-8362 | 63629-8362-1 | 30 TABLET in 1 BOTTLE (63629-8362-1) |
COLCHICINE | colchicine | TABLET;ORAL | 211250 | ANDA | Bryant Ranch Prepack | 63629-8362 | 63629-8362-2 | 20 TABLET in 1 BOTTLE (63629-8362-2) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.6MG | ||||
Approval Date: | Feb 8, 2019 | TE: | AB | RLD: | No |
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