FDA NDA · NDA018652

HYDROCORTISONE BUTYRATE

Sponsor: PRECISION DERMAT

APPLICATION

NDA018652

TYPE

NDA

ORIGINAL APPROVAL

1982-10-29

LATEST ACTION

2014-10-30

ROUTE

TOPICAL

DOSAGE FORM

OINTMENT

MARKETING STATUS

Discontinued

Products

LOCOID · ReferenceDiscontinued

HYDROCORTISONE BUTYRATE 0.1% · OINTMENT · TOPICAL

2014-10-30Labeling · Supplement 10 · standard — Letter ↗AP

2013-05-03Manufacturing (CMC) · Supplement 9 · standardAP

1996-07-16Manufacturing (CMC) · Supplement 5 · standardAP

1995-04-25Manufacturing (CMC) · Supplement 3 · standardAP

1995-02-24Manufacturing (CMC) · Supplement 4 · standardAP

1985-02-20Manufacturing (CMC) · Supplement 1 · standardAP

1982-10-29Type 3 - New Dosage Form · Original · standardAP

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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