Details for New Drug Application (NDA): 215463
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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 215463
Tradename: | COLCHICINE |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | colchicine |
Patents: | 0 |
Suppliers and Packaging for NDA: 215463
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
COLCHICINE | colchicine | CAPSULE;ORAL | 215463 | ANDA | Aurobindo Pharma Limited | 59651-446 | 59651-446-01 | 100 CAPSULE in 1 BOTTLE (59651-446-01) |
COLCHICINE | colchicine | CAPSULE;ORAL | 215463 | ANDA | Aurobindo Pharma Limited | 59651-446 | 59651-446-99 | 1000 CAPSULE in 1 BOTTLE (59651-446-99) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.6MG | ||||
Approval Date: | Apr 29, 2024 | TE: | AB | RLD: | No |
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