amcinonide Topical Ointment

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc. (2014-04-08)
Oldest Current Product
2003-03-19
License(s)
ANDA
RxNORM
TOPICAL OINTMENT\AMCINONIDE
FDAOB
TOPICAL\OINTMENT\AMCINONIDE
SPL Active
TOPICAL\OINTMENT\AMCINONIDE
SPL Moiety
TOPICAL\OINTMENT\AMCINONIDE

product(s) by strength(s)

amcinonide 0.001 mg/mg topical ointment

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001680279ANDAE. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.2014-04-03AMCINONIDETOPICALOINTMENTANDA0760963a386f5e-530d-446b-a0fb-6b9a667ad23f
2516724060ANDATaro Pharmaceuticals U.S.A., Inc.2003-03-19AMCINONIDETOPICALOINTMENTANDA076367ac5c3e79-52f7-434e-92ae-24bd32b45edc

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA076096AMCINONIDEFOUGERA PHARMACEUTICALS INC2002-11-19ANDA076096_001
2ANDA076367AMCINONIDETARO PHARMACEUTICAL INDUSTRIES LTD2003-03-19ANDA076367_001
3NDA018498CYCLOCORTTrueASTELLAS PHARMA US INCNDA018498_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076096_001RXAMCINONIDE (0.1%)TOPICALOINTMENTTrueAB2002-11-19AMCINONIDE
2ANDA076367_001RXAMCINONIDE (0.1%)TOPICALOINTMENTFalseAB2003-03-19AMCINONIDE
3NDA018498_001discontinuedAMCINONIDE (0.1%)TOPICALOINTMENTFalseCYCLOCORT

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
13a386f5e-530d-446b-a0fb-6b9a667ad23f (view SPL)AMCINONIDE OINTMENT USP, 0.1%prescriptionHuman PrescriptionE. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.2014-04-084001680279
2ac5c3e79-52f7-434e-92ae-24bd32b45edc (view SPL)Amcinonide Cream USP, 0.1% Amcinonide Ointment USP, 0.1%prescriptionHuman PrescriptionTaro Pharmaceuticals U.S.A., Inc.MANUFACTURE2012-02-062516724060, 516724054amcinonide Topical Cream

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