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FDA ANDA · ANDA089440
HYDROCORTISONE ACETATE 1% AND PRAMOXINE HYDROCHLORIDE 1%
Sponsor: GENUS
APPLICATION
ANDA089440
TYPE
ANDA
ORIGINAL APPROVAL
1988-05-17
LATEST ACTION
2000-08-11
ROUTE
TOPICAL
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Discontinued
Products
HYDROCORTISONE ACETATE 1% AND PRAMOXINE HYDROCHLORIDE 1%Discontinued
HYDROCORTISONE ACETATE 1%, PRAMOXINE HYDROCHLORIDE 1% · AEROSOL, METERED · TOPICAL
Approval history
2000-08-11Manufacturing (CMC) · Supplement 7AP
1999-09-07Manufacturing (CMC) · Supplement 3AP
1999-06-17Manufacturing (CMC) · Supplement 6AP
1999-03-23Manufacturing (CMC) · Supplement 5AP
1998-07-07Labeling · Supplement 2AP
1998-06-10Manufacturing (CMC) · Supplement 4AP
1996-05-31Manufacturing (CMC) · Supplement 1AP
1988-05-17OriginalAP
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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