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As of Nov 13, 2026, NDA 16741 (Sorbitol 3.3% In Plastic Container), held by B Braun, was first approved by FDA on Feb 16, 1978, with 33 approved supplements and 0 published complete response letters.
First approved: Feb 16, 1978
Review: Standard
Supplements approved: 33
Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 34 submissions below
Date
Submission
Status
Documents
Feb 16, 1978
Original applicationNew formulation or manufacturer · Standard review
Approved
None posted
Products
1 strengths and forms
Product
Active ingredient
Marketing
Sorbitol 3.3% In Plastic Container3.3GM/100ML · solution;irrigation
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
