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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 210906


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NDA 210906 describes CALCIUM GLUCONATE IN SODIUM CHLORIDE, which is a drug marketed by Amneal, Fresenius Kabi Usa, and Hq Spclt Pharma, and is included in three NDAs. It is available from seven 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.
Summary for 210906
Pharmacology for NDA: 210906
Suppliers and Packaging for NDA: 210906
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CALCIUM GLUCONATE IN SODIUM CHLORIDE 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
CALCIUM GLUCONATE IN SODIUM CHLORIDE 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

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength1GM/50ML (20MG/ML)
Approval Date:Oct 29, 2018TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Jul 25, 2037Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Jul 25, 2037Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength2GM/100ML (20MG/ML)
Approval Date:Oct 29, 2018TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Jul 25, 2037Product Flag?YSubstance Flag?Delist Request?

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