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FDA ANDA · ANDA040259

HYDROCORTISONE ACETATE

Sponsor: IMPERIUM

APPLICATION
ANDA040259
TYPE
ANDA
ORIGINAL APPROVAL
1999-07-29
LATEST ACTION
2001-08-24
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued

Products

HYDROCORTISONE ACETATEDiscontinued
HYDROCORTISONE ACETATE 2.5% · CREAM · TOPICAL

Approval history

2001-08-24Manufacturing (CMC) · Supplement 6AP
2001-07-13Manufacturing (CMC) · Supplement 4AP
2001-07-13Manufacturing (CMC) · Supplement 2AP
2001-07-13Manufacturing (CMC) · Supplement 3AP
2000-10-31Manufacturing (CMC) · Supplement 1AP
1999-07-29Original — Review ↗AP
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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