APPLICATION
NDA020453
TYPE
NDA
ORIGINAL APPROVAL
1997-02-28
LATEST ACTION
2017-01-25
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued
Products
PANDEL · ReferenceDiscontinued
HYDROCORTISONE PROBUTATE 0.1% · CREAM · TOPICAL
Approval history
2015-10-20Manufacturing (CMC) · Supplement 5 · standardAP
1997-02-28Type 2 - New Active Ingredient · 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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