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Last Updated: July 3, 2020

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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 Hq Spclt Pharma and is included in one NDA. It is available from one supplier. 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. Five 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
Formulation / Manufacturing:see details
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 44567-620-24 24 POUCH in 1 CARTON (44567-620-24) > 1 BAG in 1 POUCH (44567-620-01) > 50 mL in 1 BAG
CALCIUM GLUCONATE IN SODIUM CHLORIDE calcium gluconate SOLUTION;INTRAVENOUS 210906 NDA WG Critical Care, LLC 44567-621 44567-621-24 24 POUCH in 1 CARTON (44567-621-24) > 1 BAG in 1 POUCH (44567-621-01) > 100 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:  Start TrialPatent Expiration:Jul 25, 2037Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent 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:  Start TrialPatent Expiration:Jul 25, 2037Product Flag?YSubstance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

Colorcon
McKesson
Merck
Baxter
Mallinckrodt
Boehringer Ingelheim

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