APPLICATION
NDA018161
TYPE
NDA
ORIGINAL APPROVAL
1979-08-06
LATEST ACTION
2003-05-15
ROUTE
IRRIGATION, IRRIGATION, URETHRAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
ACETIC ACID 0.25% IN PLASTIC CONTAINERPrescription
ACETIC ACID, GLACIAL 250MG/100ML · SOLUTION · IRRIGATION, URETHRAL
Approval history
2003-05-15Labeling · Supplement 22AP
2002-08-28Manufacturing (CMC) · Supplement 21 · standardAP
2002-04-10Manufacturing (CMC) · Supplement 20 · standardAP
1998-06-16Manufacturing (CMC) · Supplement 19 · standardAP
1990-09-11Manufacturing (CMC) · Supplement 18 · standardAP
1987-03-05Manufacturing (CMC) · Supplement 14 · standardAP
1986-01-03Labeling · Supplement 15AP
1985-06-04Manufacturing (CMC) · Supplement 11 · standardAP
1985-05-17Manufacturing (CMC) · Supplement 12 · standardAP
1985-04-03Manufacturing (CMC) · Supplement 13 · standardAP
1982-08-09Labeling · Supplement 10AP
1981-11-06Manufacturing (CMC) · Supplement 7 · standardAP
1981-09-28Manufacturing (CMC) · Supplement 8 · standardAP
1981-09-24Manufacturing (CMC) · Supplement 9 · standardAP
1981-03-18Manufacturing (CMC) · Supplement 6 · standardAP
1980-07-16Manufacturing (CMC) · Supplement 5 · standardAP
1980-02-15Manufacturing (CMC) · Supplement 4 · standardAP
1979-12-04Labeling · Supplement 3AP
1979-09-25Labeling · Supplement 2AP
1979-09-24Manufacturing (CMC) · Supplement 1 · standardAP
1979-08-06Type 5 - New Formulation or New Manufacturer · Original · 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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