Details for New Drug Application (NDA): 208418
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NDA 208418 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 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 are two hundred and eighty-two drug master file entries for this compound. Twelve 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. Twelve 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: | 1 |
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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