Details for New Drug Application (NDA): 210425
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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 210425
Tradename: | COLCHICINE |
Applicant: | Granules |
Ingredient: | colchicine |
Patents: | 0 |
Pharmacology for NDA: 210425
Mechanism of Action | Cytochrome P450 3A4 Inhibitors P-Glycoprotein Interactions |
Medical Subject Heading (MeSH) Categories for 210425
Suppliers and Packaging for NDA: 210425
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
COLCHICINE | colchicine | TABLET;ORAL | 210425 | ANDA | Major Pharmaceuticals | 0904-7120 | 0904-7120-04 | 30 BLISTER PACK in 1 CARTON (0904-7120-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
COLCHICINE | colchicine | TABLET;ORAL | 210425 | ANDA | Golden State Medical Supply, Inc. | 51407-082 | 51407-082-01 | 100 TABLET, FILM COATED in 1 BOTTLE (51407-082-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.6MG | ||||
Approval Date: | Feb 5, 2020 | TE: | AB | RLD: | No |
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