← FDA DRUG APPROVALS

FDA NDA · NDA017351

CORTIFOAM

hydrocortisone acetate

Sponsor: VIATRIS

APPLICATION
NDA017351
TYPE
NDA
ORIGINAL APPROVAL
1982-02-12
LATEST ACTION
2024-03-01
ROUTE
TOPICAL, RECTAL
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Prescription

Products

CORTIFOAM · ReferencePrescription
HYDROCORTISONE ACETATE 10% · AEROSOL, METERED · RECTAL

Approval history

2024-03-01Labeling · Supplement 41 · standard — Label ↗AP
2014-10-03Manufacturing (CMC) · Supplement 37 · standardAP
2003-12-05Labeling · Supplement 30 · standard — Letter ↗AP
2002-11-20Manufacturing (CMC) · Supplement 28 · standardAP
2002-07-08Labeling · Supplement 27 · standard — Letter ↗AP
1999-12-01Manufacturing (CMC) · Supplement 26 · standardAP
1999-08-05Manufacturing (CMC) · Supplement 25 · standardAP
1998-08-21Manufacturing (CMC) · Supplement 24 · standardAP
1998-06-08Manufacturing (CMC) · Supplement 23 · standardAP
1998-03-16Manufacturing (CMC) · Supplement 22 · standardAP
1997-05-13Manufacturing (CMC) · Supplement 19 · standardAP
1996-12-27Manufacturing (CMC) · Supplement 21 · standardAP
1996-12-27Manufacturing (CMC) · Supplement 20 · standardAP
1996-11-29Manufacturing (CMC) · Supplement 18 · standardAP
1996-03-28Manufacturing (CMC) · Supplement 17 · standardAP
1995-07-17Manufacturing (CMC) · Supplement 16 · standardAP
1995-05-02Manufacturing (CMC) · Supplement 15 · standardAP
1994-12-05Manufacturing (CMC) · Supplement 14 · standardAP
1993-11-05Manufacturing (CMC) · Supplement 13 · standardAP
1993-10-15Labeling · Supplement 12AP
1986-04-24Manufacturing (CMC) · Supplement 11 · standardAP
1985-06-06Manufacturing (CMC) · Supplement 4 · standardAP
1984-11-20Manufacturing (CMC) · Supplement 10 · standardAP
1983-04-26Manufacturing (CMC) · Supplement 7 · standardAP
1982-12-30Manufacturing (CMC) · Supplement 6 · standardAP
1982-09-16Manufacturing (CMC) · Supplement 5 · standardAP
1982-02-12Type 3 - New Dosage Form · Original · standardAP
1982-02-10Manufacturing (CMC) · Supplement 2 · standardAP
1982-02-10Manufacturing (CMC) · Supplement 3 · standardAP
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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