APPLICATION
ANDA085027
TYPE
ANDA
ORIGINAL APPROVAL
1977-11-30
LATEST ACTION
2000-01-03
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription
Products
HYDROCORTISONEPrescription
HYDROCORTISONE 2.5% · OINTMENT · TOPICAL
Approval history
2000-01-03Manufacturing (CMC) · Supplement 21AP
1999-08-18Manufacturing (CMC) · Supplement 19AP
1999-08-18Manufacturing (CMC) · Supplement 18AP
1999-08-18Labeling · Supplement 20AP
1996-06-18Labeling · Supplement 17AP
1989-08-14Labeling · Supplement 16AP
1986-06-11Manufacturing (CMC) · Supplement 13AP
1982-07-07Manufacturing (CMC) · Supplement 8AP
1982-06-02Manufacturing (CMC) · Supplement 9AP
1977-11-30OriginalAP
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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