APPLICATION
ANDA088759
TYPE
ANDA
ORIGINAL APPROVAL
1985-03-04
LATEST ACTION
2005-04-28
ROUTE
AURICULAR (OTIC), OTIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription
Products
HYDROCORTISONE AND ACETIC ACID · ReferencePrescription
ACETIC ACID, GLACIAL 2%, HYDROCORTISONE 1% · SOLUTION/DROPS · OTIC
Approval history
2005-04-28Labeling · Supplement 22AP
1999-08-24Labeling · Supplement 17AP
1996-06-13Manufacturing (CMC) · Supplement 15AP
1993-02-12Labeling · Supplement 14AP
1992-10-01Labeling · Supplement 13AP
1992-07-17Labeling · Supplement 11AP
1992-04-28Labeling · Supplement 12AP
1991-03-27Manufacturing (CMC) · Supplement 10AP
1989-08-31Manufacturing (CMC) · Supplement 9AP
1989-01-12Labeling · Supplement 8AP
1988-04-19Labeling · Supplement 7AP
1988-03-01Manufacturing (CMC) · Supplement 6AP
1986-08-21Manufacturing (CMC) · Supplement 3AP
1986-08-15Manufacturing (CMC) · Supplement 4AP
1985-12-04Manufacturing (CMC) · Supplement 1AP
1985-03-04OriginalAP
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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