Details for New Drug Application (NDA): 217174
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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 217174
Tradename: | CALCIUM GLUCONATE IN SODIUM CHLORIDE |
Applicant: | Amneal |
Ingredient: | calcium gluconate |
Patents: | 0 |
Pharmacology for NDA: 217174
Mechanism of Action | Phosphate Chelating Activity |
Physiological Effect | Increased Coagulation Factor Activity |
Suppliers and Packaging for NDA: 217174
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CALCIUM GLUCONATE IN SODIUM CHLORIDE | calcium gluconate | SOLUTION;INTRAVENOUS | 217174 | ANDA | Amneal Pharmaceuticals Private Limited | 80830-2362 | 80830-2362-2 | 12 POUCH in 1 CARTON (80830-2362-2) / 1 BAG in 1 POUCH / 50 mL in 1 BAG |
CALCIUM GLUCONATE IN SODIUM CHLORIDE | calcium gluconate | SOLUTION;INTRAVENOUS | 217174 | ANDA | Amneal Pharmaceuticals Private Limited | 80830-2362 | 80830-2362-9 | 24 POUCH in 1 CARTON (80830-2362-9) / 1 BAG in 1 POUCH / 50 mL in 1 BAG |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 1GM/50ML (20MG/ML) | ||||
Approval Date: | Sep 5, 2023 | TE: | AP | RLD: | No | ||||
Regulatory Exclusivity Expiration: | Mar 10, 2024 | ||||||||
Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 2GM/100ML (20MG/ML) | ||||
Approval Date: | Sep 5, 2023 | TE: | AP | RLD: | No | ||||
Regulatory Exclusivity Expiration: | Mar 10, 2024 | ||||||||
Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY |
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