Details for New Drug Application (NDA): 204711
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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 204711
Tradename: | COLCHICINE |
Applicant: | Amneal Pharms |
Ingredient: | colchicine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 204711
Mechanism of Action | Cytochrome P450 3A4 Inhibitors P-Glycoprotein Interactions |
Medical Subject Heading (MeSH) Categories for 204711
Suppliers and Packaging for NDA: 204711
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
COLCHICINE | colchicine | TABLET;ORAL | 204711 | ANDA | AvPAK | 50268-187 | 50268-187-15 | 50 BLISTER PACK in 1 BOX (50268-187-15) / 1 TABLET in 1 BLISTER PACK (50268-187-11) |
COLCHICINE | colchicine | TABLET;ORAL | 204711 | ANDA | Amneal Pharmaceuticals LLC | 65162-710 | 65162-710-03 | 30 TABLET in 1 BOTTLE (65162-710-03) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.6MG | ||||
Approval Date: | Sep 28, 2016 | TE: | AB | RLD: | No |
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