APPLICATION
NDA017633
TYPE
NDA
ORIGINAL APPROVAL
1976-05-25
LATEST ACTION
1999-09-24
ROUTE
IRRIGATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
GLYCINE 1.5% IN PLASTIC CONTAINERDiscontinued
GLYCINE 1.5GM/100ML · SOLUTION · IRRIGATION
Approval history
1999-09-24Labeling · Supplement 46 · standardAP
1999-09-03Manufacturing (CMC) · Supplement 49 · standardAP
1999-02-12Manufacturing (CMC) · Supplement 48 · standardAP
1998-02-10Manufacturing (CMC) · Supplement 47 · standardAP
1997-05-05Manufacturing (CMC) · Supplement 45 · standardAP
1996-08-30Manufacturing (CMC) · Supplement 44 · standardAP
1996-08-27Manufacturing (CMC) · Supplement 43 · standardAP
1993-12-30Manufacturing (CMC) · Supplement 42 · standardAP
1993-08-24Manufacturing (CMC) · Supplement 38 · standardAP
1992-06-30Manufacturing (CMC) · Supplement 40 · standardAP
1990-06-01Labeling · Supplement 39 · standardAP
1988-11-25Manufacturing (CMC) · Supplement 37 · standardAP
1986-01-18Manufacturing (CMC) · Supplement 34 · standardAP
1985-10-29Manufacturing (CMC) · Supplement 36 · standardAP
1984-10-22Manufacturing (CMC) · Supplement 33 · standardAP
1984-08-25Manufacturing (CMC) · Supplement 31 · standardAP
1984-03-15Manufacturing (CMC) · Supplement 30 · standardAP
1984-03-01Manufacturing (CMC) · Supplement 29 · standardAP
1983-02-17Labeling · Supplement 24 · standardAP
1982-06-10Manufacturing (CMC) · Supplement 28 · standardAP
1981-11-06Manufacturing (CMC) · Supplement 26 · standardAP
1981-09-02Manufacturing (CMC) · Supplement 27 · standardAP
1981-07-21Manufacturing (CMC) · Supplement 17 · standardAP
1981-04-29Manufacturing (CMC) · Supplement 25 · standardAP
1980-10-01Labeling · Supplement 23 · standardAP
1980-09-08Manufacturing (CMC) · Supplement 22 · standardAP
1980-06-27Labeling · Supplement 21 · standardAP
1980-06-06Manufacturing (CMC) · Supplement 20 · standardAP
1980-05-23Manufacturing (CMC) · Supplement 18 · standardAP
1980-03-20Manufacturing (CMC) · Supplement 16 · standardAP
1979-10-04Manufacturing (CMC) · Supplement 13 · standardAP
1979-07-31Manufacturing (CMC) · Supplement 11 · standardAP
1979-07-18Manufacturing (CMC) · Supplement 10 · standardAP
1979-06-18Manufacturing (CMC) · Supplement 12 · standardAP
1979-05-01Manufacturing (CMC) · Supplement 9 · standardAP
1978-08-29Manufacturing (CMC) · Supplement 8 · standardAP
1978-01-17Manufacturing (CMC) · Supplement 7 · standardAP
1977-07-21Manufacturing (CMC) · Supplement 1 · standardAP
1977-05-25Manufacturing (CMC) · Supplement 4 · standardAP
1977-05-05Manufacturing (CMC) · Supplement 6 · 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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