APPLICATION
NDA017513
TYPE
NDA
ORIGINAL APPROVAL
1974-04-08
LATEST ACTION
2014-09-24
ROUTE
IRRIGATION
DOSAGE FORM
LIQUID
MARKETING STATUS
Prescription
Products
STERILE WATER IN PLASTIC CONTAINERPrescription
STERILE WATER FOR IRRIGATION 100% · LIQUID · IRRIGATION
Approval history
2014-09-24Manufacturing (CMC) · Supplement 61 · standardAP
1998-02-10Manufacturing (CMC) · Supplement 50 · standardAP
1996-08-27Manufacturing (CMC) · Supplement 49 · standardAP
1993-08-24Manufacturing (CMC) · Supplement 46 · standardAP
1992-06-30Manufacturing (CMC) · Supplement 47 · standardAP
1988-11-28Manufacturing (CMC) · Supplement 45 · standardAP
1986-11-12Manufacturing (CMC) · Supplement 43 · standardAP
1986-01-18Manufacturing (CMC) · Supplement 42 · standardAP
1985-10-29Manufacturing (CMC) · Supplement 44 · standardAP
1984-10-22Manufacturing (CMC) · Supplement 41 · standardAP
1984-08-25Manufacturing (CMC) · Supplement 39 · standardAP
1984-03-15Manufacturing (CMC) · Supplement 38 · standardAP
1984-03-01Manufacturing (CMC) · Supplement 37 · standardAP
1982-08-26Labeling · Supplement 33AP
1982-06-10Manufacturing (CMC) · Supplement 36 · standardAP
1981-11-06Manufacturing (CMC) · Supplement 35 · standardAP
1981-07-21Manufacturing (CMC) · Supplement 27 · standardAP
1981-03-03Labeling · Supplement 34AP
1980-10-06Labeling · Supplement 31AP
1980-10-01Labeling · Supplement 32AP
1980-06-06Manufacturing (CMC) · Supplement 30 · standardAP
1980-05-23Manufacturing (CMC) · Supplement 28 · standardAP
1980-03-20Manufacturing (CMC) · Supplement 26 · standardAP
1979-10-04Manufacturing (CMC) · Supplement 23 · standardAP
1979-07-30Manufacturing (CMC) · Supplement 22 · standardAP
1979-07-16Manufacturing (CMC) · Supplement 21 · standardAP
1979-05-01Manufacturing (CMC) · Supplement 18 · standardAP
1979-04-23Labeling · Supplement 20AP
1979-01-03Labeling · Supplement 19AP
1978-12-01Manufacturing (CMC) · Supplement 17 · standardAP
1978-11-22Manufacturing (CMC) · Supplement 15 · standardAP
1978-11-22Labeling · Supplement 16AP
1978-10-16Manufacturing (CMC) · Supplement 14 · standardAP
1978-07-12Labeling · Supplement 13AP
1978-07-12Manufacturing (CMC) · Supplement 12 · standardAP
1977-07-12Labeling · Supplement 11AP
1977-06-22Manufacturing (CMC) · Supplement 10 · standardAP
1977-01-28Manufacturing (CMC) · Supplement 9 · standardAP
1976-04-20Labeling · Supplement 8AP
1976-03-29Labeling · Supplement 7AP
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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