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FDA ANDA · ANDA080474

HYTONE

Sponsor: DERMIK LABS

APPLICATION
ANDA080474
TYPE
ANDA
ORIGINAL APPROVAL
1972-09-26
LATEST ACTION
1991-12-09
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued

Products

HYTONE · ReferenceDiscontinued
HYDROCORTISONE 2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · OINTMENT · TOPICAL
HYTONE · ReferenceDiscontinued
HYDROCORTISONE 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · OINTMENT · TOPICAL

Approval history

1991-12-09Labeling · Supplement 22AP
1972-09-26OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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