fluocinolone Topical Ointment

Brand(s)
Synalar
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Medimetriks Pharmaceuticals Inc (2012-12-17)
Oldest Current Product
1982-12-16
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
TOPICAL OINTMENT\FLUOCINOLONE
FDAOB
TOPICAL\OINTMENT\FLUOCINOLONE ACETONIDE
SPL Active
TOPICAL\OINTMENT\FLUOCINOLONE ACETONIDE
SPL Moiety
TOPICAL\OINTMENT\FLUOCINOLONE ACETONIDE

product(s) by strength(s)

fluocinolone acetonide 0.00025 mg/mg topical ointment

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1435380910SynalarNDAMedimetriks Pharmaceuticals Inc2012-09-27FLUOCINOLONE ACETONIDETOPICALOINTMENTNDA013960d2d155cf-a635-4ab7-87de-34e90b9a74cd

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001680064ANDAE. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.1982-12-16FLUOCINOLONE ACETONIDETOPICALOINTMENTANDA08816849552e29-7813-4726-b15d-63bd975b6588
2007130224ANDAG&W Laboratories, Inc.1988-07-26FLUOCINOLONE ACETONIDETOPICALOINTMENTANDA089524de5b78ab-ff79-3e0f-cad4-ecab11ebbdcd
3525650013NDA AUTHORIZED GENERICIgi Labs, Inc.2012-12-27FLUOCINOLONE ACETONIDETOPICALOINTMENTNDA013960dbf0ae16-5180-4397-9012-7e5181074511

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040041FLUOCINOLONE ACETONIDETARO PHARMACEUTICALS INC1994-09-15ANDA040041_001
2ANDA087157FLUONIDTrueALLERGAN HERBERT DIV ALLERGAN INC1984-09-06ANDA087157_001
3ANDA088046FLUOCINOLONE ACETONIDETruePHARMADERM DIV ALTANA INC1982-12-16ANDA088046_001
4ANDA088168FLUOCINOLONE ACETONIDEE FOUGERA DIV ALTANA INC1982-12-16ANDA088168_001
5ANDA088172FLUOTREXTrueSAVAGE LABORATORIES INC DIV ALTANA INC1983-03-09ANDA088172_001
6ANDA088507FLUOCINOLONE ACETONIDETruePHARMAFAIR INC1984-02-27ANDA088507_001
7ANDA088742FLUOCINOLONE ACETONIDETrueUSL PHARMA INC1985-02-08ANDA088742_001
8ANDA089524FLUOCINOLONE ACETONIDEG AND W LABORATORIES INC1988-07-26ANDA089524_001
9NDA013960SYNALARMEDIMETRIKS PHARMACEUTICALS INCNDA013960_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040041_001RXFLUOCINOLONE ACETONIDE (0.025%)TOPICALOINTMENTFalseAT1994-09-15FLUOCINOLONE ACETONIDE
2ANDA087157_001discontinuedFLUOCINOLONE ACETONIDE (0.025%)TOPICALOINTMENTFalse1984-09-06FLUONID
3ANDA088046_001discontinuedFLUOCINOLONE ACETONIDE (0.025%)TOPICALOINTMENTFalse1982-12-16FLUOCINOLONE ACETONIDE
4ANDA088168_001RXFLUOCINOLONE ACETONIDE (0.025%)TOPICALOINTMENTFalseAT1982-12-16FLUOCINOLONE ACETONIDE
5ANDA088172_001discontinuedFLUOCINOLONE ACETONIDE (0.025%)TOPICALOINTMENTFalse1983-03-09FLUOTREX
6ANDA088507_001discontinuedFLUOCINOLONE ACETONIDE (0.025%)TOPICALOINTMENTFalse1984-02-27FLUOCINOLONE ACETONIDE
7ANDA088742_001discontinuedFLUOCINOLONE ACETONIDE (0.025%)TOPICALOINTMENTFalse1985-02-08FLUOCINOLONE ACETONIDE
8ANDA089524_001RXFLUOCINOLONE ACETONIDE (0.025%)TOPICALOINTMENTFalseAT1988-07-26FLUOCINOLONE ACETONIDE
9NDA013960_001RXFLUOCINOLONE ACETONIDE (0.025%)TOPICALOINTMENTTrueATSYNALAR

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
149552e29-7813-4726-b15d-63bd975b6588 (view SPL)FLUOCINOLONE ACETONIDE OINTMENT, USP, 0.025%prescriptionHuman PrescriptionE. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.2014-01-246001680064
2d2d155cf-a635-4ab7-87de-34e90b9a74cd (view SPL)SYNALAR (fluocinolone acetonide) Ointment 0.025%prescriptionHuman PrescriptionMedimetriks Pharmaceuticals IncMANUFACTURE2012-12-172435380910, 435380911
3dbf0ae16-5180-4397-9012-7e5181074511 (view SPL)Fluocinolone Acetonide Ointment USP, 0.025%prescriptionHuman PrescriptionIgi Labs, Inc.MANUFACTURE2012-12-261525650013
4de5b78ab-ff79-3e0f-cad4-ecab11ebbdcd (view SPL)Fluocinolone Acetonide Cream, USP 0.025% Fluocinolone Acetonide Cream, USP 0.01%Fluocinolone Acetonide Ointment, USP 0.025% Topical CorticosteroidprescriptionHuman PrescriptionG&W Laboratories, Inc.MANUFACTURE2011-09-0210007130224, 007130222, 007130223fluocinolone Topical Cream

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