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FDA ANDA · ANDA080692

HYDROCORTISONE

Sponsor: FOUGERA PHARMS

APPLICATION
ANDA080692
TYPE
ANDA
ORIGINAL APPROVAL
1975-04-16
LATEST ACTION
1996-03-07
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription

Products

HYDROCORTISONE · ReferencePrescription
HYDROCORTISONE 1% · OINTMENT · TOPICAL

Approval history

1996-03-07Manufacturing (CMC) · Supplement 26AP
1995-11-08Manufacturing (CMC) · Supplement 25AP
1995-08-07Manufacturing (CMC) · Supplement 24AP
1987-07-30Manufacturing (CMC) · Supplement 22AP
1984-01-26Manufacturing (CMC) · Supplement 20AP
1982-07-13Manufacturing (CMC) · Supplement 14AP
1982-07-13Manufacturing (CMC) · Supplement 12AP
1982-07-13Manufacturing (CMC) · Supplement 9AP
1982-07-13Manufacturing (CMC) · Supplement 15AP
1982-07-13Manufacturing (CMC) · Supplement 13AP
1982-07-13Manufacturing (CMC) · Supplement 8AP
1975-04-16OriginalAP
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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