Details for New Drug Application (NDA): 217020
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NDA 217020 describes PROBENECID, which is a drug marketed by Aurobindo Pharma Usa, Ivax Sub Teva Pharms, Lederle, Rising, Watson Labs, Watson Labs Teva, Ani Pharms, Beecham, Impax Labs, Novast Labs, and Sandoz, and is included in fourteen NDAs. It is available from three suppliers. Additional details are available on the PROBENECID profile page.
The generic ingredient in PROBENECID 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 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 217020
| Tradename: | PROBENECID |
| Applicant: | Rising |
| Ingredient: | probenecid |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 217020
Suppliers and Packaging for NDA: 217020
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROBENECID | probenecid | TABLET;ORAL | 217020 | ANDA | Rising Pharma Holdings, Inc. | 16571-831 | 16571-831-01 | 100 TABLET in 1 CONTAINER (16571-831-01) |
| PROBENECID | probenecid | TABLET;ORAL | 217020 | ANDA | Rising Pharma Holdings, Inc. | 16571-831 | 16571-831-10 | 1000 TABLET in 1 CONTAINER (16571-831-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Nov 20, 2023 | TE: | AB | RLD: | No | ||||
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