APPLICATION
NDA016734
TYPE
NDA
ORIGINAL APPROVAL
1970-09-10
LATEST ACTION
2015-03-30
ROUTE
IRRIGATION
DOSAGE FORM
LIQUID
MARKETING STATUS
Prescription
Products
STERILE WATER IN PLASTIC CONTAINER · ReferencePrescription
STERILE WATER FOR IRRIGATION 100% · LIQUID · IRRIGATION
Approval history
2015-03-30Manufacturing (CMC) · Supplement 49 · standardAP
2013-05-08Manufacturing (CMC) · Supplement 48 · standardAP
2002-07-08Manufacturing (CMC) · Supplement 44 · standardAP
2002-04-03Manufacturing (CMC) · Supplement 43 · standardAP
2000-04-12Manufacturing (CMC) · Supplement 42 · standardAP
1998-03-25Manufacturing (CMC) · Supplement 41 · standardAP
1990-09-11Manufacturing (CMC) · Supplement 40 · standardAP
1988-04-19Manufacturing (CMC) · Supplement 38 · standardAP
1987-03-05Manufacturing (CMC) · Supplement 34 · standardAP
1985-08-30Manufacturing (CMC) · Supplement 36 · standardAP
1985-07-17Labeling · Supplement 35AP
1985-05-17Manufacturing (CMC) · Supplement 32 · standardAP
1985-05-15Manufacturing (CMC) · Supplement 31 · standardAP
1985-04-03Manufacturing (CMC) · Supplement 33 · standardAP
1982-10-12Labeling · Supplement 30AP
1981-11-06Manufacturing (CMC) · Supplement 27 · standardAP
1981-10-27Manufacturing (CMC) · Supplement 25 · standardAP
1981-10-27Labeling · Supplement 26AP
1981-09-28Manufacturing (CMC) · Supplement 28 · standardAP
1981-09-24Manufacturing (CMC) · Supplement 29 · standardAP
1981-03-03Labeling · Supplement 20AP
1980-07-16Manufacturing (CMC) · Supplement 24 · standardAP
1980-02-15Manufacturing (CMC) · Supplement 23 · standardAP
1980-01-04Labeling · Supplement 17AP
1979-09-25Labeling · Supplement 22AP
1979-09-24Manufacturing (CMC) · Supplement 21 · standardAP
1979-07-20Labeling · Supplement 19AP
1979-04-26Manufacturing (CMC) · Supplement 18 · standardAP
1978-12-27Labeling · Supplement 13AP
1978-12-27Manufacturing (CMC) · Supplement 12 · standardAP
1978-10-27Manufacturing (CMC) · Supplement 15 · standardAP
1978-10-27Manufacturing (CMC) · Supplement 14 · standardAP
1978-08-03Manufacturing (CMC) · Supplement 16 · standardAP
1978-05-26Manufacturing (CMC) · Supplement 11 · standardAP
1978-03-06Manufacturing (CMC) · Supplement 10 · standardAP
1978-01-19Manufacturing (CMC) · Supplement 9 · standardAP
1977-02-04Manufacturing (CMC) · Supplement 8 · standardAP
1976-08-31Labeling · Supplement 7AP
1976-04-02Manufacturing (CMC) · Supplement 5 · standardAP
1976-04-02Manufacturing (CMC) · Supplement 6 · 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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