Details for New Drug Application (NDA): 203976
✉ Email this page to a colleague
NDA 203976 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 203976
| Tradename: | COLCHICINE |
| Applicant: | Endo Operations |
| Ingredient: | colchicine |
| Patents: | 0 |
Pharmacology for NDA: 203976
| Mechanism of Action | Cytochrome P450 3A4 Inhibitors P-Glycoprotein Interactions |
Medical Subject Heading (MeSH) Categories for 203976
Suppliers and Packaging for NDA: 203976
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| COLCHICINE | colchicine | TABLET;ORAL | 203976 | ANDA | Endo USA, Inc. | 49884-171 | 49884-171-01 | 100 TABLET, FILM COATED in 1 BOTTLE (49884-171-01) |
| COLCHICINE | colchicine | TABLET;ORAL | 203976 | ANDA | Endo USA, Inc. | 49884-171 | 49884-171-11 | 30 TABLET, FILM COATED in 1 BOTTLE (49884-171-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.6MG | ||||
| Approval Date: | Aug 12, 2021 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
