← FDA DRUG APPROVALS

FDA ANDA · ANDA086457

EPIFOAM

pramoxine hydrochloride and hydrocortisone acetate

Sponsor: MYLAN SPECIALITY LP

APPLICATION
ANDA086457
TYPE
ANDA
ORIGINAL APPROVAL
1979-12-19
LATEST ACTION
2021-04-09
ROUTE
TOPICAL
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Prescription

Products

EPIFOAMPrescription
HYDROCORTISONE ACETATE 1%, PRAMOXINE HYDROCHLORIDE 1% · AEROSOL, METERED · TOPICAL

Approval history

2021-04-09Manufacturing (CMC) · Supplement 34 · unknownAP
2004-12-06Labeling · Supplement 22AP
2003-08-11Labeling · Supplement 24AP
2003-01-03Manufacturing (CMC) · Supplement 23AP
1999-11-29Manufacturing (CMC) · Supplement 21AP
1999-01-12Manufacturing (CMC) · Supplement 20AP
1998-08-07Manufacturing (CMC) · Supplement 18AP
1998-07-27Manufacturing (CMC) · Supplement 19AP
1998-07-06Manufacturing (CMC) · Supplement 17AP
1998-04-07Manufacturing (CMC) · Supplement 16AP
1998-03-18Manufacturing (CMC) · Supplement 15AP
1997-02-28Manufacturing (CMC) · Supplement 13AP
1996-09-25Manufacturing (CMC) · Supplement 14AP
1995-07-12Manufacturing (CMC) · Supplement 11AP
1995-07-12Manufacturing (CMC) · Supplement 12AP
1994-11-16Manufacturing (CMC) · Supplement 10AP
1991-12-23Labeling · Supplement 9AP
1991-01-30Labeling · Supplement 8AP
1991-01-30Labeling · Supplement 38AP
1985-12-09Manufacturing (CMC) · Supplement 7AP
1982-09-01Manufacturing (CMC) · Supplement 5AP
1979-12-19OriginalAP
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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