FDA NDA · NDA019116

LOCOID

Sponsor: BAUSCH

APPLICATION

NDA019116

TYPE

NDA

ORIGINAL APPROVAL

1987-02-25

LATEST ACTION

2014-10-30

ROUTE

TOPICAL

DOSAGE FORM

SOLUTION

MARKETING STATUS

Prescription

Products

LOCOID · ReferencePrescription

HYDROCORTISONE BUTYRATE 0.1% · SOLUTION · TOPICAL

2014-10-30Labeling · Supplement 9 · standard — Label ↗AP

2013-05-03Manufacturing (CMC) · Supplement 8 · standardAP

2002-05-09Manufacturing (CMC) · Supplement 5 · standardAP

1996-08-30Manufacturing (CMC) · Supplement 4 · standardAP

1994-11-25Manufacturing (CMC) · Supplement 3 · standardAP

1987-02-25Type 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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