APPLICATION
NDA017866
TYPE
NDA
ORIGINAL APPROVAL
1980-05-30
LATEST ACTION
2017-10-17
ROUTE
IRRIGATION
DOSAGE FORM
LIQUID
MARKETING STATUS
Prescription
Products
STERILE WATER IN PLASTIC CONTAINERPrescription
STERILE WATER FOR IRRIGATION 100% · LIQUID · IRRIGATION
Approval history
2014-09-26Manufacturing (CMC) · Supplement 53 · standardAP
2001-08-29Manufacturing (CMC) · Supplement 44 · standardAP
2000-01-28Manufacturing (CMC) · Supplement 43 · standardAP
1997-04-29Manufacturing (CMC) · Supplement 42 · standardAP
1994-09-30Manufacturing (CMC) · Supplement 40 · standardAP
1994-02-18Manufacturing (CMC) · Supplement 41 · standardAP
1993-12-08Manufacturing (CMC) · Supplement 39 · standardAP
1991-05-08Labeling · Supplement 37AP
1991-03-26Manufacturing (CMC) · Supplement 36 · standardAP
1991-02-15Manufacturing (CMC) · Supplement 34 · standardAP
1990-05-18Manufacturing (CMC) · Supplement 35 · standardAP
1989-07-26Manufacturing (CMC) · Supplement 33 · standardAP
1989-01-12Manufacturing (CMC) · Supplement 32 · standardAP
1987-07-25Manufacturing (CMC) · Supplement 30 · standardAP
1987-05-28Manufacturing (CMC) · Supplement 29 · standardAP
1986-09-08Manufacturing (CMC) · Supplement 28 · standardAP
1986-02-27Manufacturing (CMC) · Supplement 27 · standardAP
1985-08-28Manufacturing (CMC) · Supplement 21 · standardAP
1985-08-28Manufacturing (CMC) · Supplement 20 · standardAP
1985-06-13Manufacturing (CMC) · Supplement 24 · standardAP
1985-04-15Labeling · Supplement 25AP
1985-04-15Manufacturing (CMC) · Supplement 26 · standardAP
1985-01-24Manufacturing (CMC) · Supplement 6 · standardAP
1985-01-24Manufacturing (CMC) · Supplement 18 · standardAP
1984-03-16Manufacturing (CMC) · Supplement 19 · standardAP
1984-02-28Manufacturing (CMC) · Supplement 23 · standardAP
1982-12-22Manufacturing (CMC) · Supplement 13 · standardAP
1982-12-22Labeling · Supplement 14AP
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
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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