Details for New Drug Application (NDA): 217524
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NDA 217524 describes CALCIUM CHLORIDE, which is a drug marketed by Amneal, Am Regent, Intl Medication Sys, Medefil Inc, and Hospira, and is included in five NDAs. It is available from one supplier. Additional details are available on the CALCIUM CHLORIDE profile page.
The generic ingredient in CALCIUM CHLORIDE is calcium chloride. There are two hundred and eighty-two drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the calcium chloride profile page.
The generic ingredient in CALCIUM CHLORIDE is calcium chloride. There are two hundred and eighty-two drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the calcium chloride profile page.
Summary for 217524
| Tradename: | CALCIUM CHLORIDE |
| Applicant: | Amneal |
| Ingredient: | calcium chloride |
| Patents: | 0 |
Pharmacology for NDA: 217524
| Mechanism of Action | Phosphate Chelating Activity |
| Physiological Effect | Increased Coagulation Factor Activity |
Suppliers and Packaging for NDA: 217524
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CALCIUM CHLORIDE | calcium chloride | INJECTABLE;INJECTION | 217524 | ANDA | Amneal Pharmaceuticals LLC | 70121-2308 | 70121-2308-4 | 24 CARTON in 1 CARTON (70121-2308-4) / 1 SYRINGE, GLASS in 1 CARTON (70121-2308-1) / 10 mL in 1 SYRINGE, GLASS |
| CALCIUM CHLORIDE | calcium chloride | INJECTABLE;INJECTION | 217524 | ANDA | Amneal Pharmaceuticals LLC | 70121-2309 | 70121-2309-7 | 10 VIAL, GLASS in 1 CARTON (70121-2309-7) / 10 mL in 1 VIAL, GLASS (70121-2309-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 100MG/ML | ||||
| Approval Date: | Jul 8, 2024 | TE: | AP | RLD: | No | ||||
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