Details for New Drug Application (NDA): 203477
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NDA 203477 describes CALCIUM CHLORIDE 10%, which is a drug marketed by Am Regent, Intl Medication Sys, Medefil Inc, and Hospira, and is included in four NDAs. It is available from six suppliers. Additional details are available on the CALCIUM CHLORIDE 10% profile page.
The generic ingredient in CALCIUM CHLORIDE 10% is calcium chloride. There are two hundred and eighty-two drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the calcium chloride profile page.
The generic ingredient in CALCIUM CHLORIDE 10% is calcium chloride. There are two hundred and eighty-two drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the calcium chloride profile page.
Summary for 203477
| Tradename: | CALCIUM CHLORIDE 10% |
| Applicant: | Intl Medication Sys |
| Ingredient: | calcium chloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 203477
| Mechanism of Action | Phosphate Chelating Activity |
| Physiological Effect | Increased Coagulation Factor Activity |
Suppliers and Packaging for NDA: 203477
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CALCIUM CHLORIDE 10% | calcium chloride | INJECTABLE;INJECTION | 203477 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1379 | 51662-1379-1 | 1 SYRINGE in 1 CARTON (51662-1379-1) / 10 mL in 1 SYRINGE |
| CALCIUM CHLORIDE 10% | calcium chloride | INJECTABLE;INJECTION | 203477 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1379 | 51662-1379-3 | 10 POUCH in 1 CASE (51662-1379-3) / 1 CARTON in 1 POUCH (51662-1379-2) / 1 SYRINGE in 1 CARTON / 10 mL in 1 SYRINGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 100MG/ML | ||||
| Approval Date: | May 9, 2018 | TE: | AP | RLD: | No | ||||
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