Details for New Drug Application (NDA): 203477
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The generic ingredient in CALCIUM CHLORIDE 10% 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 203477
Tradename: | CALCIUM CHLORIDE 10% |
Applicant: | Intl Medication Sys |
Ingredient: | calcium chloride |
Patents: | 0 |
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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