APPLICATION
NDA017865
TYPE
NDA
ORIGINAL APPROVAL
1980-05-30
LATEST ACTION
2014-09-26
ROUTE
IRRIGATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER · ReferencePrescription
GLYCINE 1.5GM/100ML · SOLUTION · IRRIGATION
Approval history
2014-09-26Manufacturing (CMC) · Supplement 48 · standardAP
2001-08-14Manufacturing (CMC) · Supplement 42 · standardAP
1999-11-24Manufacturing (CMC) · Supplement 39 · standardAP
1997-04-29Manufacturing (CMC) · Supplement 37 · standardAP
1994-09-30Manufacturing (CMC) · Supplement 35 · standardAP
1994-02-18Manufacturing (CMC) · Supplement 36 · standardAP
1993-12-08Manufacturing (CMC) · Supplement 34 · standardAP
1991-05-08Labeling · Supplement 31AP
1991-04-26Manufacturing (CMC) · Supplement 32 · standardAP
1991-03-26Manufacturing (CMC) · Supplement 30 · standardAP
1991-02-15Manufacturing (CMC) · Supplement 29 · standardAP
1989-07-26Manufacturing (CMC) · Supplement 28 · standardAP
1989-01-12Manufacturing (CMC) · Supplement 27 · standardAP
1985-08-28Manufacturing (CMC) · Supplement 20 · standardAP
1985-08-28Manufacturing (CMC) · Supplement 21 · standardAP
1985-06-13Manufacturing (CMC) · Supplement 24 · standardAP
1985-04-15Manufacturing (CMC) · Supplement 25 · standardAP
1985-01-24Manufacturing (CMC) · Supplement 18 · standardAP
1984-03-16Manufacturing (CMC) · Supplement 19 · standardAP
1984-02-28Manufacturing (CMC) · Supplement 23 · standardAP
1982-12-22Labeling · Supplement 14AP
1982-12-22Manufacturing (CMC) · Supplement 13 · standardAP
1982-06-03Manufacturing (CMC) · Supplement 10 · standardAP
1982-04-16Manufacturing (CMC) · Supplement 9 · standardAP
1982-02-17Labeling · Supplement 16AP
1981-12-21Manufacturing (CMC) · Supplement 8 · standardAP
1981-11-20Manufacturing (CMC) · Supplement 12 · standardAP
1981-11-13Manufacturing (CMC) · Supplement 7 · standardAP
1981-06-29Manufacturing (CMC) · Supplement 5 · standardAP
1981-05-29Manufacturing (CMC) · Supplement 4 · standardAP
1981-01-21Manufacturing (CMC) · Supplement 3 · standardAP
1980-08-06Manufacturing (CMC) · Supplement 2 · standardAP
1980-07-31Manufacturing (CMC) · Supplement 1 · standardAP
1980-05-30Type 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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