Details for New Drug Application (NDA): 080966
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NDA 080966 describes PROBALAN, which is a drug marketed by Lannett and is included in one NDA. It is available from four suppliers. Additional details are available on the PROBALAN profile page.
The generic ingredient in PROBALAN is probenecid. There are ten drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the probenecid profile page.
The generic ingredient in PROBALAN is probenecid. There are ten drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the probenecid profile page.
Summary for 080966
| Tradename: | PROBALAN |
| Applicant: | Lannett |
| Ingredient: | probenecid |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 080966
Suppliers and Packaging for NDA: 080966
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROBALAN | probenecid | TABLET;ORAL | 080966 | ANDA | Lannett Company, Inc. | 0527-1367 | 0527-1367-01 | 100 TABLET, FILM COATED in 1 BOTTLE (0527-1367-01) |
| PROBALAN | probenecid | TABLET;ORAL | 080966 | ANDA | Lannett Company, Inc. | 0527-1367 | 0527-1367-10 | 1000 TABLET, FILM COATED in 1 BOTTLE (0527-1367-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | No | ||||
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