Details for New Drug Application (NDA): 211250
✉ Email this page to a colleague
NDA 211250 describes COLCHICINE, which is a drug marketed by Par Pharm Inc, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Dr Reddys, Granules, Hetero Labs Ltd V, Mylan, Strides Pharma, Watson Labs Inc, and Zydus Pharms, and is included in twelve NDAs. It is available from twenty-three 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. Twenty-nine 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. Twenty-nine 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 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 211250
| Mechanism of Action | Cytochrome P450 3A4 Inhibitors P-Glycoprotein Interactions |
Medical Subject Heading (MeSH) Categories for 211250
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 | Bryant Ranch Prepack | 63629-8362 | 63629-8362-1 | 30 TABLET in 1 BOTTLE (63629-8362-1) |
| COLCHICINE | colchicine | TABLET;ORAL | 211250 | ANDA | Bryant Ranch Prepack | 63629-8362 | 63629-8362-2 | 20 TABLET in 1 BOTTLE (63629-8362-2) |
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
