Details for New Drug Application (NDA): 217174
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NDA 217174 describes CALCIUM GLUCONATE IN SODIUM CHLORIDE, which is a drug marketed by Amneal, Fresenius Kabi Usa, Hq Spclt Pharma, and Sagent, and is included in four NDAs. It is available from eight suppliers. There are two patents protecting this drug. Additional details are available on the CALCIUM GLUCONATE IN SODIUM CHLORIDE profile page.
The generic ingredient in CALCIUM GLUCONATE IN SODIUM CHLORIDE is calcium gluconate. There is one drug master file entry for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the calcium gluconate profile page.
The generic ingredient in CALCIUM GLUCONATE IN SODIUM CHLORIDE is calcium gluconate. There is one drug master file entry for this compound. Thirteen 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 | ||||
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 | ||||
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