Details for New Drug Application (NDA): 208678
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NDA 208678 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 208678
| Tradename: | COLCHICINE |
| Applicant: | Endo Operations |
| Ingredient: | colchicine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 208678
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| COLCHICINE | colchicine | CAPSULE;ORAL | 208678 | ANDA | ENDO USA, Inc. | 0254-0460 | 0254-0460-01 | 100 CAPSULE in 1 BOTTLE (0254-0460-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.6MG | ||||
| Approval Date: | Nov 29, 2018 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Apr 29, 2024 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
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