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FDA ANDA · ANDA085282

HYDROCORTISONE

Sponsor: MERICON

APPLICATION
ANDA085282
TYPE
ANDA
ORIGINAL APPROVAL
1978-06-05
LATEST ACTION
1989-11-02
ROUTE
TOPICAL
DOSAGE FORM
LOTION
MARKETING STATUS
Discontinued

Products

HYDROCORTISONEDiscontinued
HYDROCORTISONE 1% · LOTION · TOPICAL
HYDROCORTISONEDiscontinued
HYDROCORTISONE 0.5% · LOTION · TOPICAL

Approval history

1989-11-02Labeling · Supplement 14AP
1987-02-26Manufacturing (CMC) · Supplement 11AP
1987-02-26Manufacturing (CMC) · Supplement 12AP
1987-02-26Manufacturing (CMC) · Supplement 10AP
1978-06-05OriginalAP
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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