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FDA ANDA · ANDA080706

HYDROCORTISONE

Sponsor: CROWN LABS

APPLICATION
ANDA080706
TYPE
ANDA
ORIGINAL APPROVAL
1973-03-09
LATEST ACTION
2015-09-22
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

ALA-CORTPrescription
HYDROCORTISONE 1% · CREAM · TOPICAL
ALA-CORTPrescription
HYDROCORTISONE 2.5% · CREAM · TOPICAL

Approval history

2015-09-22Labeling · Supplement 12 · standardAP
1997-01-28Labeling · Supplement 8AP
1992-05-22Labeling · Supplement 7AP
1985-07-10Manufacturing (CMC) · Supplement 5AP
1985-07-10Manufacturing (CMC) · Supplement 6AP
1982-05-12Manufacturing (CMC) · Supplement 2AP
1973-03-09OriginalAP
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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