Details for New Drug Application (NDA): 209470
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NDA 209470 describes COLCHICINE, which is a drug marketed by Annora Pharma, Aurobindo Pharma Ltd, Endo Operations, Granules, Alkem Labs Ltd, Amneal Pharms, Dr Reddys, Hetero Labs Ltd V, Mylan, Strides Pharma, Watson Labs Inc, and Zydus Pharms, and is included in fifteen NDAs. It is available from twenty-seven suppliers. Additional details are available on the COLCHICINE profile page.
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.
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) |
| COLCHICINE | colchicine | TABLET;ORAL | 209470 | ANDA | Mylan Institutional Inc. | 42292-054 | 42292-054-03 | 30 BLISTER PACK in 1 CARTON (42292-054-03) / 1 TABLET, FILM COATED in 1 BLISTER PACK (42292-054-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 0.6MG | ||||
| Approval Date: | Sep 16, 2019 | TE: | RLD: | No | |||||
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