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Last Updated: December 2, 2023

Details for New Drug Application (NDA): 021910

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NDA 021910 describes NORMOCARB HF 35, which is a drug marketed by Dialysis Sups and is included in one NDA. Additional details are available on the NORMOCARB HF 35 profile page.

The generic ingredient in NORMOCARB HF 35 is magnesium chloride; sodium bicarbonate; sodium chloride. There are one hundred and forty-six drug master file entries for this compound. Additional details are available on the magnesium chloride; sodium bicarbonate; sodium chloride profile page.

Summary for 021910

Tradename:	NORMOCARB HF 35
Applicant:	Dialysis Sups
Ingredient:	magnesium chloride; sodium bicarbonate; sodium chloride
Patents:	1

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INJECTION			Strength	0.21GM/100ML;2.8GM/100ML;9.07GM/100ML
Approval Date:	Jul 26, 2006	TE:		RLD:	Yes
Patent:	⤷ Try a Trial	Patent Expiration:	Mar 4, 2023	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	USE AS REPLACEMENT SOLUTION, HEMOFILTRATION SOLUTION OR HEMODIAFILTRATION SOLUTION IN CONTINUOUS RENAL REPLACEMENT THERAPY

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INJECTION			Strength	0.21GM/100ML;3.97GM/100ML;8.3GM/100ML
Approval Date:	Jul 26, 2006	TE:		RLD:	Yes

Expired US Patents for NDA 021910

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Dialysis Sups	NORMOCARB HF 25	magnesium chloride; sodium bicarbonate; sodium chloride	SOLUTION;INJECTION	021910-001	Jul 26, 2006	⤷ Try a Trial	⤷ Try a Trial
Dialysis Sups	NORMOCARB HF 35	magnesium chloride; sodium bicarbonate; sodium chloride	SOLUTION;INJECTION	021910-002	Jul 26, 2006	⤷ Try a Trial	⤷ Try a Trial
Dialysis Sups	NORMOCARB HF 25	magnesium chloride; sodium bicarbonate; sodium chloride	SOLUTION;INJECTION	021910-001	Jul 26, 2006	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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