Details for New Drug Application (NDA): 217689
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NDA 217689 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 217689
| Tradename: | CALCIUM GLUCONATE |
| Applicant: | Somerset |
| Ingredient: | calcium gluconate |
| Patents: | 0 |
Pharmacology for NDA: 217689
| Mechanism of Action | Phosphate Chelating Activity |
| Physiological Effect | Increased Coagulation Factor Activity |
Suppliers and Packaging for NDA: 217689
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CALCIUM GLUCONATE | calcium gluconate | SOLUTION;INTRAVENOUS | 217689 | ANDA | Somerset Therapeutics, LLC | 70069-727 | 70069-727-10 | 10 VIAL, PLASTIC in 1 CARTON (70069-727-10) / 50 mL in 1 VIAL, PLASTIC |
| CALCIUM GLUCONATE | calcium gluconate | SOLUTION;INTRAVENOUS | 217689 | ANDA | Somerset Therapeutics, LLC | 70069-727 | 70069-727-25 | 25 VIAL, PLASTIC in 1 CARTON (70069-727-25) / 50 mL in 1 VIAL, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 5GM/50ML (100MG/ML) | ||||
| Approval Date: | Oct 19, 2023 | TE: | AP | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Apr 17, 2024 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 10GM/100ML (100MG/ML) | ||||
| Approval Date: | Oct 19, 2023 | TE: | AP | RLD: | No | ||||
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