FDA Approves Glycine 1.5% Irrigation Solution (NDA 017633)

The FDA database entry for NDA 017633 documents a single product: Glycine 1.5% in a plastic container, intended for irrigation use and supplied as a solution. The product contains the active ingredient Glycine at a strength of 1.5 g per 100 mL and is listed with a marketing status of "Discontinued". The record includes a series of standard‑priority supplemental submissions (SUPPL) that received approval (status "AP"). These submissions cover manufacturing (CMC) and labeling aspects. Manufacturing (CMC) approvals were issued on 1977‑05‑05 (submission #6), 1977‑05‑25 (submission #4), 1978‑11‑25 (submission #37), 1984‑03‑01 (submission #29), 1997‑05‑05 (submission #45), 1998‑02‑10 (submission #47), 1999‑09‑03 (submission #49), and 1996‑08‑27 (submission #43). Labeling approvals were granted on 1976‑08‑18 (submission #2) and 1990‑06‑01 (submission #39). Additional manufacturing approvals were recorded on 1979‑07‑18 (submission #10) and 1997‑05‑05 (submission #45). The list reflects a long‑term regulatory history spanning more than two decades. Despite these approvals, the product’s current marketing status is listed as discontinued, indicating it is no longer commercially available.