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As of Nov 13, 2026, NDA 2282 (Inulin And Sodium Chloride), held by Iso Tex, was first approved by FDA on Apr 30, 1940, with 11 approved supplements and 0 published complete response letters.
First approved: Apr 30, 1940
Review: Standard
Supplements approved: 11
Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 12 submissions below
Date
Submission
Status
Documents
Apr 30, 1940
Original applicationNew combination · Standard review
Approved
None posted
Products
1 strengths and forms
Product
Active ingredient
Marketing
Inulin And Sodium Chloride100MG/ML · injectable;injection
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
