APPLICATION
NDA017428
TYPE
NDA
ORIGINAL APPROVAL
1974-12-31
LATEST ACTION
2017-10-17
ROUTE
IRRIGATION
DOSAGE FORM
LIQUID
MARKETING STATUS
Prescription
Products
STERILE WATER · ReferencePrescription
STERILE WATER FOR IRRIGATION 100% · LIQUID · IRRIGATION
Approval history
2016-08-04Manufacturing (CMC) · Supplement 73 · standardAP
2011-09-28Manufacturing (CMC) · Supplement 69AP
1994-09-30Manufacturing (CMC) · Supplement 58 · standardAP
1993-09-14Manufacturing (CMC) · Supplement 59 · standardAP
1991-11-14Manufacturing (CMC) · Supplement 56 · standardAP
1991-03-26Manufacturing (CMC) · Supplement 57 · standardAP
1990-05-18Manufacturing (CMC) · Supplement 55 · standardAP
1989-07-26Manufacturing (CMC) · Supplement 54 · standardAP
1986-10-30Manufacturing (CMC) · Supplement 53 · standardAP
1985-04-06Labeling · Supplement 52AP
1985-01-24Manufacturing (CMC) · Supplement 48 · standardAP
1985-01-24Manufacturing (CMC) · Supplement 40 · standardAP
1984-02-28Manufacturing (CMC) · Supplement 50 · standardAP
1982-12-22Manufacturing (CMC) · Supplement 44 · standardAP
1982-12-22Manufacturing (CMC) · Supplement 45 · standardAP
1982-12-22Manufacturing (CMC) · Supplement 43 · standardAP
1982-06-07Manufacturing (CMC) · Supplement 46 · standardAP
1982-04-09Labeling · Supplement 34AP
1982-04-09Manufacturing (CMC) · Supplement 30 · standardAP
1982-04-09Manufacturing (CMC) · Supplement 33 · standardAP
1982-03-01Labeling · Supplement 31AP
1982-02-16Manufacturing (CMC) · Supplement 42 · standardAP
1981-08-06Manufacturing (CMC) · Supplement 38 · standardAP
1981-06-29Manufacturing (CMC) · Supplement 37 · standardAP
1981-06-10Manufacturing (CMC) · Supplement 41 · standardAP
1981-02-23Manufacturing (CMC) · Supplement 36 · standardAP
1981-01-22Labeling · Supplement 35AP
1980-07-31Manufacturing (CMC) · Supplement 32 · standardAP
1980-06-02Labeling · Supplement 28AP
1980-06-02Manufacturing (CMC) · Supplement 27 · standardAP
1979-12-19Manufacturing (CMC) · Supplement 29 · standardAP
1979-12-11Manufacturing (CMC) · Supplement 13 · standardAP
1979-12-11Manufacturing (CMC) · Supplement 20 · standardAP
1979-12-11Manufacturing (CMC) · Supplement 19 · standardAP
1979-05-29Manufacturing (CMC) · Supplement 26 · standardAP
1979-03-14Manufacturing (CMC) · Supplement 24 · standardAP
1979-02-14Manufacturing (CMC) · Supplement 22 · standardAP
1979-02-08Labeling · Supplement 25AP
1978-06-20Manufacturing (CMC) · Supplement 21 · 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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