APPLICATION
NDA012179
TYPE
NDA
ORIGINAL APPROVAL
1960-05-17
LATEST ACTION
1997-10-16
ROUTE
OTIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
VOSOL · ReferenceDiscontinued
ACETIC ACID, GLACIAL 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION/DROPS · OTIC
Approval history
1997-10-16Manufacturing (CMC) · Supplement 19 · standardAP
1997-07-29Labeling · Supplement 18 · standardAP
1995-12-21Manufacturing (CMC) · Supplement 16 · standardAP
1988-06-29Labeling · Supplement 15AP
1987-08-03Labeling · Supplement 12AP
1986-08-26Manufacturing (CMC) · Supplement 14 · standardAP
1985-06-24Manufacturing (CMC) · Supplement 13 · standardAP
1984-06-06Manufacturing (CMC) · Supplement 11 · standardAP
1984-06-06Labeling · Supplement 8AP
1975-06-02Manufacturing (CMC) · Supplement 6 · standardAP
1974-07-16Supplement · Supplement 5 · standardAP
1960-05-17Type 4 - New Combination · 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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