Hydrocortisone Rectal Foam

Brand(s)
Cortifoam
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Meda Pharmaceuticals Inc. (2015-05-31)
Oldest Current Product
2015-06-30
License(s)
NDA
RxNORM
RECTAL FOAM\HYDROCORTISONE
FDAOB
RECTAL\AEROSOL, METERED\HYDROCORTISONE ACETATE
SPL Active
TOPICAL\AEROSOL, FOAM\HYDROCORTISONE ACETATE
SPL Moiety
TOPICAL\AEROSOL, FOAM\HYDROCORTISONE

product(s) by strength(s)

hydrocortisone acetate 100 mg/ml rectal foam

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000376830CortifoamNDAMeda Pharmaceuticals Inc.2015-06-30HYDROCORTISONE ACETATETOPICALAEROSOL, FOAMNDA0173510093b694-9fcb-46ae-b1ab-7d0fa204c6c8

application(s)

#idtitleapplicantapprovedapproved drug
1NDA017351CORTIFOAMMEDA PHARMACEUTICALS INC1982-02-10NDA017351_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA017351_001RXHYDROCORTISONE ACETATE (10%)RECTALAEROSOL, METEREDTrue1982-02-10CORTIFOAM

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
10093b694-9fcb-46ae-b1ab-7d0fa204c6c8 (view SPL)cortifoam (hydrocortisone acetate rectal aerosol) 10% Rectal FoamprescriptionHuman PrescriptionMeda Pharmaceuticals Inc.2015-05-311000376830
2ef91f4f9-6345-48b8-a9a1-b7a7038f8fb7 (view SPL)cortifoam (hydrocortisone acetate rectal aerosol) 10% Rectal FoamprescriptionHuman PrescriptionAlaven Pharmaceutical2009-11-181682200140

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII