Details for New Drug Application (NDA): 217030
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NDA 217030 describes PROBENECID AND COLCHICINE, which is a drug marketed by Ani Pharms, Beecham, Impax Labs, Novast Labs, Rising, and Sandoz, and is included in six NDAs. It is available from two suppliers. Additional details are available on the PROBENECID AND COLCHICINE profile page.
The generic ingredient in PROBENECID AND COLCHICINE is colchicine; probenecid. There are sixteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the colchicine; probenecid profile page.
The generic ingredient in PROBENECID AND COLCHICINE is colchicine; probenecid. There are sixteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the colchicine; probenecid profile page.
Summary for 217030
| Tradename: | PROBENECID AND COLCHICINE |
| Applicant: | Rising |
| Ingredient: | colchicine; probenecid |
| Patents: | 0 |
Pharmacology for NDA: 217030
| Mechanism of Action | Cytochrome P450 3A4 Inhibitors P-Glycoprotein Interactions |
Suppliers and Packaging for NDA: 217030
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROBENECID AND COLCHICINE | colchicine; probenecid | TABLET;ORAL | 217030 | ANDA | Rising Pharma Holdings, Inc. | 16571-832 | 16571-832-01 | 100 TABLET in 1 CONTAINER (16571-832-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG;500MG | ||||
| Approval Date: | Oct 24, 2023 | TE: | AB | RLD: | No | ||||
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