APPLICATION
NDA018313
TYPE
NDA
ORIGINAL APPROVAL
1980-02-22
LATEST ACTION
2004-04-09
ROUTE
IRRIGATION
DOSAGE FORM
LIQUID
MARKETING STATUS
Prescription
Products
STERILE WATER IN PLASTIC CONTAINERPrescription
STERILE WATER FOR IRRIGATION 100% · LIQUID · IRRIGATION
Approval history
2004-04-09Labeling · Supplement 48AP
1997-08-21Manufacturing (CMC) · Supplement 46 · standardAP
1997-06-11Manufacturing (CMC) · Supplement 45 · standardAP
1997-03-28Manufacturing (CMC) · Supplement 44 · standardAP
1996-10-22Manufacturing (CMC) · Supplement 43 · standardAP
1996-08-29Manufacturing (CMC) · Supplement 42 · standardAP
1996-08-27Manufacturing (CMC) · Supplement 41 · standardAP
1995-08-14Manufacturing (CMC) · Supplement 39 · standardAP
1992-01-28Manufacturing (CMC) · Supplement 35 · standardAP
1991-09-10Manufacturing (CMC) · Supplement 34 · standardAP
1991-08-30Manufacturing (CMC) · Supplement 36 · standardAP
1990-02-22Manufacturing (CMC) · Supplement 31 · standardAP
1990-01-11Manufacturing (CMC) · Supplement 32 · standardAP
1989-06-14Manufacturing (CMC) · Supplement 30 · standardAP
1987-07-30Manufacturing (CMC) · Supplement 27 · standardAP
1986-11-26Manufacturing (CMC) · Supplement 26 · standardAP
1986-08-08Manufacturing (CMC) · Supplement 25 · standardAP
1986-02-22Manufacturing (CMC) · Supplement 21 · standardAP
1986-02-22Labeling · Supplement 22AP
1986-02-21Manufacturing (CMC) · Supplement 24 · standardAP
1986-01-31Manufacturing (CMC) · Supplement 23 · standardAP
1985-10-29Manufacturing (CMC) · Supplement 17 · standardAP
1985-09-26Manufacturing (CMC) · Supplement 19 · standardAP
1984-10-22Manufacturing (CMC) · Supplement 20 · standardAP
1984-10-17Manufacturing (CMC) · Supplement 16 · standardAP
1984-09-22Labeling · Supplement 13AP
1984-09-22Manufacturing (CMC) · Supplement 12 · standardAP
1984-03-21Manufacturing (CMC) · Supplement 15 · standardAP
1984-03-01Manufacturing (CMC) · Supplement 14 · standardAP
1984-03-01Manufacturing (CMC) · Supplement 10 · standardAP
1982-08-26Labeling · Supplement 4AP
1982-07-26Manufacturing (CMC) · Supplement 11 · standardAP
1982-06-09Manufacturing (CMC) · Supplement 7 · standardAP
1982-02-01Manufacturing (CMC) · Supplement 9 · standardAP
1982-01-08Manufacturing (CMC) · Supplement 8 · standardAP
1981-09-16Manufacturing (CMC) · Supplement 5 · standardAP
1981-04-29Manufacturing (CMC) · Supplement 6 · standardAP
1980-09-15Manufacturing (CMC) · Supplement 3 · standardAP
1980-07-03Manufacturing (CMC) · Supplement 1 · standardAP
1980-07-03Labeling · Supplement 2AP
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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