APPLICATION
NDA016784
TYPE
NDA
ORIGINAL APPROVAL
1978-02-06
LATEST ACTION
2014-09-12
ROUTE
IRRIGATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
GLYCINE 1.5% IN PLASTIC CONTAINERPrescription
GLYCINE 1.5GM/100ML · SOLUTION · IRRIGATION
Approval history
2013-05-08Manufacturing (CMC) · Supplement 34 · standardAP
2002-07-08Manufacturing (CMC) · Supplement 30 · standardAP
2002-04-03Manufacturing (CMC) · Supplement 29 · standardAP
2000-04-12Manufacturing (CMC) · Supplement 28 · standardAP
1998-03-25Manufacturing (CMC) · Supplement 27 · standardAP
1997-05-21Manufacturing (CMC) · Supplement 26 · standardAP
1995-01-13Manufacturing (CMC) · Supplement 25 · standardAP
1990-09-11Manufacturing (CMC) · Supplement 24 · standardAP
1988-04-19Manufacturing (CMC) · Supplement 22 · standardAP
1987-03-05Manufacturing (CMC) · Supplement 19 · standardAP
1985-07-27Labeling · Supplement 20AP
1985-05-24Manufacturing (CMC) · Supplement 16 · standardAP
1985-05-17Manufacturing (CMC) · Supplement 17 · standardAP
1985-04-03Manufacturing (CMC) · Supplement 18 · standardAP
1983-02-18Labeling · Supplement 15AP
1981-11-06Manufacturing (CMC) · Supplement 12 · standardAP
1981-10-27Labeling · Supplement 11AP
1981-10-27Manufacturing (CMC) · Supplement 10 · standardAP
1981-09-28Manufacturing (CMC) · Supplement 13 · standardAP
1981-09-24Manufacturing (CMC) · Supplement 14 · standardAP
1980-07-16Manufacturing (CMC) · Supplement 9 · standardAP
1980-02-15Manufacturing (CMC) · Supplement 8 · standardAP
1979-09-25Labeling · Supplement 7AP
1979-09-24Manufacturing (CMC) · Supplement 6 · standardAP
1979-06-19Labeling · Supplement 3AP
1979-04-26Manufacturing (CMC) · Supplement 4 · standardAP
1979-04-12Labeling · Supplement 5AP
1978-10-30Manufacturing (CMC) · Supplement 1 · standardAP
1978-08-28Manufacturing (CMC) · Supplement 2 · standardAP
1978-02-06Type 5 - New Formulation or New Manufacturer · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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