Details for New Drug Application (NDA): 009175
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NDA 009175 describes FURADANTIN, which is a drug marketed by Casper Pharma Llc and Procter And Gamble and is included in two NDAs. It is available from two suppliers. Additional details are available on the FURADANTIN profile page.
The generic ingredient in FURADANTIN is nitrofurantoin. There are twenty drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the nitrofurantoin profile page.
The generic ingredient in FURADANTIN is nitrofurantoin. There are twenty drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the nitrofurantoin profile page.
Summary for 009175
| Tradename: | FURADANTIN |
| Applicant: | Casper Pharma Llc |
| Ingredient: | nitrofurantoin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 009175
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FURADANTIN | nitrofurantoin | SUSPENSION;ORAL | 009175 | NDA AUTHORIZED GENERIC | Rising Pharma Holdings, Inc. | 16571-740 | 16571-740-24 | 1 BOTTLE in 1 CARTON (16571-740-24) / 230 mL in 1 BOTTLE |
| FURADANTIN | nitrofurantoin | SUSPENSION;ORAL | 009175 | NDA AUTHORIZED GENERIC | Rising Pharma Holdings, Inc. | 16571-888 | 16571-888-06 | 1 BOTTLE in 1 CARTON (16571-888-06) / 60 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 25MG/5ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 50MG/5ML | ||||
| Approval Date: | Jun 9, 2023 | TE: | RLD: | Yes | |||||
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