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, and Hq Spclt Pharma, and is included in three NDAs. It is available from six 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 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 gluconate profile page.
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. Ten 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 |
| Formulation / Manufacturing: | see details |
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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