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FDA ANDA · ANDA080693

HYDROCORTISONE

Sponsor: FOUGERA PHARMS INC

APPLICATION
ANDA080693
TYPE
ANDA
ORIGINAL APPROVAL
1976-04-30
LATEST ACTION
1996-06-10
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

HYDROCORTISONE · ReferencePrescription
HYDROCORTISONE 1% · CREAM · TOPICAL

Approval history

1996-06-10Manufacturing (CMC) · Supplement 50AP
1996-03-07Manufacturing (CMC) · Supplement 51AP
1987-07-30Manufacturing (CMC) · Supplement 48AP
1986-02-10Manufacturing (CMC) · Supplement 46AP
1986-02-10Manufacturing (CMC) · Supplement 44AP
1986-02-10Manufacturing (CMC) · Supplement 45AP
1984-01-26Manufacturing (CMC) · Supplement 43AP
1982-05-11Manufacturing (CMC) · Supplement 39AP
1976-04-30OriginalAP
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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