Normocarb Hf 25, Normocarb Hf 35

NDA 21910, held by Dialysis Sups. Magnesium Chloride; Sodium Bicarbonate; Sodium Chloride.

As of Nov 15, 2026, NDA 21910 (Normocarb Hf 25, Normocarb Hf 35), held by Dialysis Sups, was first approved by FDA on Jul 26, 2006, with 2 approved supplements and 0 published complete response letters.

First approved: Jul 26, 2006
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jul 26, 2006	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

2 strengths and forms


Normocarb Hf 250.21GM/100ML;2.8GM/100ML;9.07GM/100ML · solution;injection	Magnesium Chloride; Sodium Bicarbonate; Sodium Chloride	RxReference drug
Normocarb Hf 350.21GM/100ML;3.97GM/100ML;8.3GM/100ML · solution;injection	Magnesium Chloride; Sodium Bicarbonate; Sodium Chloride	RxReference drug

All 3 submissions, including labeling and manufacturing supplements


May 1, 2019	Supplement 8Labeling · Standard review	Approved	Letter Label
Jun 22, 2012	Supplement 5Labeling	Approved	Label Letter
Jul 26, 2006	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21910
Drugs@FDA: Overview at FDA
Company: Dialysis Sups

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters