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FDA ANDA · ANDA080473

HYTONE

Sponsor: VALEANT INTL

APPLICATION
ANDA080473
TYPE
ANDA
ORIGINAL APPROVAL
1972-09-25
LATEST ACTION
2002-03-27
ROUTE
TOPICAL
DOSAGE FORM
LOTION
MARKETING STATUS
Discontinued

Products

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HYDROCORTISONE 2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · LOTION · TOPICAL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HYDROCORTISONE 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · LOTION · TOPICAL

Approval history

2002-03-27Manufacturing (CMC) · Supplement 20AP
1999-03-04Manufacturing (CMC) · Supplement 19AP
1998-01-20Manufacturing (CMC) · Supplement 18AP
1993-11-30Manufacturing (CMC) · Supplement 17AP
1992-01-27Manufacturing (CMC) · Supplement 15AP
1992-01-27Manufacturing (CMC) · Supplement 16AP
1983-11-02Manufacturing (CMC) · Supplement 12AP
1983-07-08Manufacturing (CMC) · Supplement 11AP
1983-01-11Manufacturing (CMC) · Supplement 7AP
1982-11-30Manufacturing (CMC) · Supplement 8AP
1982-11-30Manufacturing (CMC) · Supplement 9AP
1972-09-25OriginalAP
VIEW ON DRUGS@FDA ↗

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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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