Details for New Drug Application (NDA): 209173
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The generic ingredient in COLCHICINE 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 209173
Tradename: | COLCHICINE |
Applicant: | Strides Pharma |
Ingredient: | colchicine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209173
Mechanism of Action | Cytochrome P450 3A4 Inhibitors P-Glycoprotein Interactions |
Medical Subject Heading (MeSH) Categories for 209173
Suppliers and Packaging for NDA: 209173
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
COLCHICINE | colchicine | TABLET;ORAL | 209173 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-855 | 23155-855-01 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (23155-855-01) |
COLCHICINE | colchicine | TABLET;ORAL | 209173 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-855 | 23155-855-03 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (23155-855-03) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.6MG | ||||
Approval Date: | Mar 10, 2022 | TE: | AB | RLD: | No |
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