Details for New Drug Application (NDA): 210906
✉ Email this page to a colleague
NDA 210906 describes CALCIUM GLUCONATE IN SODIUM CHLORIDE, which is a drug marketed by Amneal, Fresenius Kabi Usa, Hq Spclt Pharma, and Sagent, and is included in four 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 is one drug master file entry for this compound. Thirteen 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 is one drug master file entry for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the calcium gluconate profile page.
Summary for 210906
| Tradename: | CALCIUM GLUCONATE IN SODIUM CHLORIDE |
| Applicant: | Hq Spclt Pharma |
| Ingredient: | calcium gluconate |
| Patents: | 2 |
Pharmacology for NDA: 210906
| Mechanism of Action | Phosphate Chelating Activity |
| Physiological Effect | Increased Coagulation Factor Activity |
Suppliers and Packaging for NDA: 210906
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CALCIUM GLUCONATE | calcium gluconate | SOLUTION;INTRAVENOUS | 210906 | NDA | WG Critical Care, LLC | 44567-620 | 44567-620-24 | 24 POUCH in 1 CARTON (44567-620-24) / 1 BAG in 1 POUCH (44567-620-01) / 50 mL in 1 BAG |
| CALCIUM GLUCONATE | calcium gluconate | SOLUTION;INTRAVENOUS | 210906 | NDA | WG Critical Care, LLC | 44567-620 | 44567-620-84 | 24 POUCH in 1 CARTON (44567-620-84) / 1 BAG in 1 POUCH (44567-620-02) / 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: | Oct 29, 2018 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jul 25, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jul 25, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 2GM/100ML (20MG/ML) | ||||
| Approval Date: | Oct 29, 2018 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jul 25, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Complete Access Available with Subscription
