Details for New Drug Application (NDA): 211250
NDA 211250 describes COLCHICINE, which is a drug marketed by Annora Pharma, Aurobindo Pharma Ltd, Granules, Micro Labs, Ph Health, Alkem Labs Ltd, Amneal Pharms, Dr Reddys, Hetero Labs Ltd V, Macleods Pharms, Mylan, Strides Pharma, Watson Labs Inc, and Zydus Pharms, and is included in seventeen NDAs. It is available from thirty suppliers. Additional details are available on the COLCHICINE profile page.
The generic ingredient in COLCHICINE is colchicine. There is one drug master file entry for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the colchicine profile page.
The generic ingredient in COLCHICINE is colchicine. There is one drug master file entry for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the colchicine profile page.
Summary for 211250
| Tradename: | COLCHICINE |
| Applicant: | Alkem Labs Ltd |
| Ingredient: | colchicine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 211250
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| COLCHICINE | colchicine | TABLET;ORAL | 211250 | ANDA | A-S Medication Solutions | 50090-8014 | 50090-8014-7 | 4 TABLET in 1 BOTTLE (50090-8014-7) |
| COLCHICINE | colchicine | TABLET;ORAL | 211250 | ANDA | ST. MARY'S MEDICAL PARK PHARMACY | 60760-839 | 60760-839-10 | 10 TABLET in 1 BOTTLE, PLASTIC (60760-839-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.6MG | ||||
| Approval Date: | Feb 8, 2019 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
