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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 216611


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NDA 216611 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.
Summary for 216611
Tradename:CALCIUM GLUCONATE
Applicant:Amneal
Ingredient:calcium gluconate
Patents:0
Pharmacology for NDA: 216611
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:RXDosage:SOLUTION;INTRAVENOUSStrength1GM/10ML (100MG/ML)
Approval Date:May 10, 2024TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength5GM/50ML (100MG/ML)
Approval Date:May 10, 2024TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength10GM/100ML (100MG/ML)
Approval Date:May 10, 2024TE:APRLD:No

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