Details for New Drug Application (NDA): 219619
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NDA 219619 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 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 IN SODIUM CHLORIDE 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 219619
| Tradename: | CALCIUM GLUCONATE IN SODIUM CHLORIDE |
| Applicant: | Sagent |
| Ingredient: | calcium gluconate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 1GM/50ML (20MG/ML) | ||||
| Approval Date: | Dec 30, 2025 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 2GM/100ML (20MG/ML) | ||||
| Approval Date: | Dec 30, 2025 | TE: | AP | RLD: | No | ||||
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