Details for New Drug Application (NDA): 208418
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The generic ingredient in CALCIUM GLUCONATE IN SODIUM CHLORIDE is calcium gluconate. There are two hundred and eighty-two drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the calcium gluconate profile page.
Summary for 208418
Tradename: | CALCIUM GLUCONATE IN SODIUM CHLORIDE |
Applicant: | Fresenius Kabi Usa |
Ingredient: | calcium gluconate |
Patents: | 0 |
Pharmacology for NDA: 208418
Mechanism of Action | Phosphate Chelating Activity |
Physiological Effect | Increased Coagulation Factor Activity |
Suppliers and Packaging for NDA: 208418
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CALCIUM GLUCONATE | calcium gluconate | SOLUTION;INTRAVENOUS | 208418 | NDA | Henry Schein, Inc. | 0404-9831 | 0404-9831-10 | 1 VIAL, PLASTIC in 1 BAG (0404-9831-10) / 10 mL in 1 VIAL, PLASTIC |
CALCIUM GLUCONATE | calcium gluconate | SOLUTION;INTRAVENOUS | 208418 | NDA | Henry Schein, Inc. | 0404-9831 | 0404-9831-50 | 1 VIAL, PLASTIC in 1 BAG (0404-9831-50) / 50 mL in 1 VIAL, PLASTIC |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 1GM/10ML (100MG/ML) | ||||
Approval Date: | Jun 15, 2017 | TE: | AP | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 5GM/50ML (100MG/ML) | ||||
Approval Date: | Jun 15, 2017 | TE: | AP | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 10GM/100ML (100MG/ML) | ||||
Approval Date: | Jun 15, 2017 | TE: | AP | RLD: | Yes |
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