Details for New Drug Application (NDA): 209470
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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 209470
| Tradename: | COLCHICINE |
| Applicant: | Mylan |
| Ingredient: | colchicine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 209470
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| COLCHICINE | colchicine | TABLET;ORAL | 209470 | ANDA | Mylan Pharmaceuticals Inc. | 0378-1086 | 0378-1086-01 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1086-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.6MG | ||||
| Approval Date: | Sep 16, 2019 | TE: | AB | RLD: | No | ||||
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