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FDA ANDA · ANDA080472

HYTONE

Sponsor: VALEANT INTL

APPLICATION
ANDA080472
TYPE
ANDA
ORIGINAL APPROVAL
1972-09-27
LATEST ACTION
2002-03-27
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued

Products

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HYDROCORTISONE 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CREAM · TOPICAL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HYDROCORTISONE 2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CREAM · TOPICAL

Approval history

2002-03-27Manufacturing (CMC) · Supplement 30AP
1992-01-27Manufacturing (CMC) · Supplement 28AP
1992-01-27Manufacturing (CMC) · Supplement 27AP
1985-03-15Manufacturing (CMC) · Supplement 25AP
1983-11-15Manufacturing (CMC) · Supplement 20AP
1983-11-15Manufacturing (CMC) · Supplement 21AP
1983-07-08Manufacturing (CMC) · Supplement 18AP
1982-04-08Manufacturing (CMC) · Supplement 6AP
1982-04-08Manufacturing (CMC) · Supplement 16AP
1982-04-08Manufacturing (CMC) · Supplement 15AP
1982-02-26Manufacturing (CMC) · Supplement 17AP
1972-09-27OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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