Details for New Drug Application (NDA): 217583
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NDA 217583 describes MANGANESE CHLORIDE, which is a drug marketed by Fresenius Kabi Usa and Hospira and is included in two NDAs. It is available from one supplier. Additional details are available on the MANGANESE CHLORIDE profile page.
The generic ingredient in MANGANESE CHLORIDE is manganese chloride. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the manganese chloride profile page.
The generic ingredient in MANGANESE CHLORIDE is manganese chloride. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the manganese chloride profile page.
Summary for 217583
| Tradename: | MANGANESE CHLORIDE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | manganese chloride |
| Patents: | 0 |
Pharmacology for NDA: 217583
| Mechanism of Action | Magnetic Resonance Contrast Activity |
Suppliers and Packaging for NDA: 217583
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MANGANESE CHLORIDE | manganese chloride | INJECTABLE;INJECTION | 217583 | ANDA | Fresenius Kabi USA, LLC | 65219-530 | 65219-530-10 | 25 VIAL, PLASTIC in 1 TRAY (65219-530-10) / 10 mL in 1 VIAL, PLASTIC (65219-530-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.1MG MANGANESE/ML | ||||
| Approval Date: | Jul 7, 2025 | TE: | AP | RLD: | No | ||||
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