Details for New Drug Application (NDA): 084442
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NDA 084442 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 084442
| Tradename: | PROBENECID |
| Applicant: | Watson Labs Teva |
| Ingredient: | probenecid |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 084442
Suppliers and Packaging for NDA: 084442
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROBENECID | probenecid | TABLET;ORAL | 084442 | ANDA | Actavis Pharma, Inc. | 0591-5347 | 0591-5347-01 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-5347-01) |
| PROBENECID | probenecid | TABLET;ORAL | 084442 | ANDA | Actavis Pharma, Inc. | 0591-5347 | 0591-5347-10 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-5347-10) |
Profile for product number 004
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Mar 29, 1983 | TE: | AB | RLD: | No | ||||
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