APPLICATION
ANDA086155
TYPE
ANDA
ORIGINAL APPROVAL
1978-07-24
LATEST ACTION
2005-04-28
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued
Products
HYDROCORTISONEDiscontinued
HYDROCORTISONE 1% · CREAM · TOPICAL
Approval history
2005-04-28Labeling · Supplement 42AP
2001-06-20Manufacturing (CMC) · Supplement 39AP
1993-04-29Labeling · Supplement 36AP
1992-11-23Labeling · Supplement 35AP
1992-11-16Labeling · Supplement 34AP
1991-01-23Labeling · Supplement 32AP
1991-01-03Manufacturing (CMC) · Supplement 31AP
1989-12-15Labeling · Supplement 29AP
1989-11-13Labeling · Supplement 28AP
1989-07-31Manufacturing (CMC) · Supplement 27AP
1989-04-26Labeling · Supplement 26AP
1987-01-08Manufacturing (CMC) · Supplement 20AP
1986-01-10Manufacturing (CMC) · Supplement 18AP
1985-11-13Manufacturing (CMC) · Supplement 17AP
1984-10-02Manufacturing (CMC) · Supplement 16AP
1984-07-03Manufacturing (CMC) · Supplement 12AP
1983-08-18Manufacturing (CMC) · Supplement 13AP
1982-07-09Manufacturing (CMC) · Supplement 11AP
1982-06-02Manufacturing (CMC) · Supplement 3AP
1982-06-02Manufacturing (CMC) · Supplement 8AP
1982-06-02Manufacturing (CMC) · Supplement 4AP
1982-06-02Manufacturing (CMC) · Supplement 2AP
1978-07-24OriginalAP
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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