Details for New Drug Application (NDA): 216541
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NDA 216541 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 216541
| Tradename: | CALCIUM GLUCONATE |
| Applicant: | B Braun Medical Inc |
| Ingredient: | calcium gluconate |
| Patents: | 0 |
Pharmacology for NDA: 216541
| Mechanism of Action | Phosphate Chelating Activity |
| Physiological Effect | Increased Coagulation Factor Activity |
Suppliers and Packaging for NDA: 216541
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CALCIUM GLUCONATE | calcium gluconate | SOLUTION;INTRAVENOUS | 216541 | ANDA | B. Braun Medical Inc. | 0264-5600 | 0264-5600-52 | 24 CONTAINER in 1 CASE (0264-5600-52) / 100 mL in 1 CONTAINER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 10GM/100ML (100MG/ML) | ||||
| Approval Date: | Aug 21, 2023 | TE: | AP | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Apr 30, 2024 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
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