Details for New Drug Application (NDA): 217131
NDA 217131 describes ASCORBIC ACID, which is a drug marketed by Fresenius Kabi Usa, Pharmobedient, and Zydus Pharms, and is included in three NDAs. It is available from four suppliers. Additional details are available on the ASCORBIC ACID profile page.
The generic ingredient in ASCORBIC ACID is ascorbic acid. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the ascorbic acid profile page.
The generic ingredient in ASCORBIC ACID is ascorbic acid. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the ascorbic acid profile page.
Summary for 217131
| Tradename: | ASCORBIC ACID |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | ascorbic acid |
| Patents: | 0 |
Suppliers and Packaging for NDA: 217131
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ASCORBIC ACID | ascorbic acid | SOLUTION;INTRAVENOUS | 217131 | ANDA | Fresenius Kabi USA, LLC | 65219-027 | 65219-027-50 | 25 VIAL, GLASS in 1 TRAY (65219-027-50) / 50 mL in 1 VIAL, GLASS (65219-027-05) |
| ASCORBIC ACID | ascorbic acid | SOLUTION;INTRAVENOUS | 217131 | ANDA | Fresenius Kabi USA, LLC | 65219-027 | 65219-027-55 | 1 VIAL, GLASS in 1 CARTON (65219-027-55) / 50 mL in 1 VIAL, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 25,000MG/50ML (500MG/ML) | ||||
| Approval Date: | Aug 7, 2025 | TE: | AP | RLD: | No | ||||
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