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As of Nov 13, 2026, NDA 16784 (Glycine 1.5% In Plastic Container), held by B Braun, was first approved by FDA on Feb 6, 1978, with 30 approved supplements and 0 published complete response letters.
First approved: Feb 6, 1978
Review: Standard
Supplements approved: 30
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
INDICATIONS AND USAGE 1.5% Glycine Irrigation USP is indicated as an irrigant during transurethral prostatic or bladder surgery.
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
