Details for New Drug Application (NDA): 213071
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NDA 213071 describes CALCIUM GLUCONATE, which is a drug marketed by Amneal, B Braun Medical Inc, Fresenius Kabi Usa, Nivagen Pharms Inc, Somerset, and Hq Spclt Pharma, and is included in seven NDAs. It is available from ten suppliers. There are two patents protecting this drug. Additional details are available on the CALCIUM GLUCONATE profile page.
The generic ingredient in CALCIUM GLUCONATE 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.
The generic ingredient in CALCIUM GLUCONATE 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 213071
| Tradename: | CALCIUM GLUCONATE |
| Applicant: | Nivagen Pharms Inc |
| Ingredient: | calcium gluconate |
| Patents: | 0 |
Pharmacology for NDA: 213071
| Mechanism of Action | Phosphate Chelating Activity |
| Physiological Effect | Increased Coagulation Factor Activity |
Suppliers and Packaging for NDA: 213071
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CALCIUM GLUCONATE | calcium gluconate | SOLUTION;INTRAVENOUS | 213071 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9180 | 0143-9180-25 | 25 VIAL in 1 CARTON (0143-9180-25) / 10 mL in 1 VIAL (0143-9180-01) |
| CALCIUM GLUCONATE | calcium gluconate | SOLUTION;INTRAVENOUS | 213071 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9184 | 0143-9184-25 | 25 VIAL in 1 CARTON (0143-9184-25) / 50 mL in 1 VIAL (0143-9184-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 1GM/10ML (100MG/ML) | ||||
| Approval Date: | Oct 14, 2022 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 5GM/50ML (100MG/ML) | ||||
| Approval Date: | Oct 19, 2023 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 10GM/100ML (100MG/ML) | ||||
| Approval Date: | Apr 30, 2024 | TE: | AP | RLD: | No | ||||
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