Details for New Drug Application (NDA): 216611
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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 216611
Tradename: | CALCIUM GLUCONATE |
Applicant: | Amneal |
Ingredient: | calcium gluconate |
Patents: | 0 |
Pharmacology for NDA: 216611
Mechanism of Action | Phosphate Chelating Activity |
Physiological Effect | Increased Coagulation Factor Activity |
Suppliers and Packaging for NDA: 216611
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CALCIUM GLUCONATE | calcium gluconate | SOLUTION;INTRAVENOUS | 216611 | ANDA | Amneal Pharmaceuticals Private Limited | 80830-1672 | 80830-1672-2 | 10 VIAL in 1 CARTON (80830-1672-2) / 10 mL in 1 VIAL (80830-1672-1) |
CALCIUM GLUCONATE | calcium gluconate | SOLUTION;INTRAVENOUS | 216611 | ANDA | Amneal Pharmaceuticals Private Limited | 80830-1672 | 80830-1672-5 | 25 VIAL in 1 CARTON (80830-1672-5) / 10 mL in 1 VIAL (80830-1672-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 1GM/10ML (100MG/ML) | ||||
Approval Date: | May 10, 2024 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 5GM/50ML (100MG/ML) | ||||
Approval Date: | May 10, 2024 | TE: | AP | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 10GM/100ML (100MG/ML) | ||||
Approval Date: | May 10, 2024 | TE: | AP | RLD: | No |
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