APPLICATION
ANDA088638
TYPE
ANDA
ORIGINAL APPROVAL
1984-09-06
LATEST ACTION
2001-04-30
ROUTE
OTIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
ACETIC ACIDDiscontinued
ACETIC ACID, GLACIAL 2% · SOLUTION/DROPS · OTIC
Approval history
2001-04-30Labeling · Supplement 17AP
1999-11-22Labeling · Supplement 16AP
1993-04-06Labeling · Supplement 15AP
1993-03-15Labeling · Supplement 14AP
1989-12-20Labeling · Supplement 13AP
1989-08-31Manufacturing (CMC) · Supplement 12AP
1988-08-29Labeling · Supplement 11AP
1988-08-11Labeling · Supplement 10AP
1988-03-01Manufacturing (CMC) · Supplement 8AP
1986-08-15Manufacturing (CMC) · Supplement 6AP
1985-12-04Manufacturing (CMC) · Supplement 4AP
1984-11-30Manufacturing (CMC) · Supplement 2AP
1984-11-30Manufacturing (CMC) · Supplement 3AP
1984-10-17Manufacturing (CMC) · Supplement 1AP
1984-09-06OriginalAP
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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