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FDA ANDA · ANDA086195

PROCTOFOAM HC

pramoxine hydrochloride hydrocortisone acetate

Sponsor: MYLAN SPECIALITY LP

APPLICATION
ANDA086195
TYPE
ANDA
ORIGINAL APPROVAL
1978-07-26
LATEST ACTION
2021-01-21
ROUTE
TOPICAL
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Prescription

Products

PROCTOFOAM HC · ReferencePrescription
HYDROCORTISONE ACETATE 1%, PRAMOXINE HYDROCHLORIDE 1% · AEROSOL, METERED · TOPICAL

Approval history

2021-01-21Manufacturing (CMC) · Supplement 52 · unknownAP
2004-12-06Labeling · Supplement 38AP
2003-08-11Labeling · Supplement 40AP
2003-08-11Labeling · Supplement 37AP
2003-01-03Manufacturing (CMC) · Supplement 39AP
2000-04-21Manufacturing (CMC) · Supplement 36AP
1999-11-29Manufacturing (CMC) · Supplement 35AP
1999-01-12Manufacturing (CMC) · Supplement 34AP
1998-08-07Manufacturing (CMC) · Supplement 32AP
1998-05-07Manufacturing (CMC) · Supplement 33AP
1998-02-25Manufacturing (CMC) · Supplement 30AP
1998-02-25Manufacturing (CMC) · Supplement 29AP
1998-02-25Labeling · Supplement 31AP
1997-08-11Manufacturing (CMC) · Supplement 28AP
1997-06-03Manufacturing (CMC) · Supplement 27AP
1997-02-28Manufacturing (CMC) · Supplement 25AP
1995-01-26Labeling · Supplement 24AP
1994-11-16Manufacturing (CMC) · Supplement 23AP
1991-01-30Labeling · Supplement 22AP
1990-08-28Labeling · Supplement 21AP
1989-02-08Labeling · Supplement 20AP
1985-12-09Manufacturing (CMC) · Supplement 15AP
1983-07-08Manufacturing (CMC) · Supplement 10AP
1982-09-01Manufacturing (CMC) · Supplement 11AP
1982-05-27Manufacturing (CMC) · Supplement 8AP
1982-04-30Manufacturing (CMC) · Supplement 9AP
1982-04-30Manufacturing (CMC) · Supplement 5AP
1982-04-30Manufacturing (CMC) · Supplement 6AP
1982-04-30Manufacturing (CMC) · Supplement 4AP
1978-07-26OriginalAP
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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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