Fluocinonide Topical Ointment

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Teva Pharmaceuticals Usa Inc (2015-04-21)
Oldest Current Product
1992-05-01
License(s)
ANDA
RxNORM
TOPICAL OINTMENT\FLUOCINONIDE
FDAOB
TOPICAL\GEL\FLUOCINONIDE
TOPICAL\OINTMENT\FLUOCINONIDE
SPL Active
TOPICAL\OINTMENT\FLUOCINONIDE
SPL Moiety
TOPICAL\OINTMENT\FLUOCINONIDE

product(s) by strength(s)

fluocinonide 0.0005 mg/mg topical ointment

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000930264ANDATeva Pharmaceuticals Usa Inc1992-05-01FLUOCINONIDETOPICALOINTMENTANDA073481986c1ba3-2103-4773-a35c-2c0121a01783
2001680140ANDAE. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.1997-08-26FLUOCINONIDETOPICALOINTMENTANDA074905c2cf3e9b-dca2-492d-a3c1-833c4250b937
3516721264ANDATaro Pharmaceuticals U.S.A., Inc.1999-06-30FLUOCINONIDETOPICALOINTMENTANDA075008b0bc89a9-c9d5-4adb-9785-2d4487c4c656

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950979ANDARebel Distributors Corp2011-01-20FLUOCINONIDETOPICALOINTMENT000930264ANDA073481b4b09d4a-dbe9-4f41-ac04-d4f71743722f
2545694210ANDAA-S Medication Solutions Llc1999-06-30FLUOCINONIDETOPICALOINTMENT516721264ANDA0750080ae0c3dd-0413-4d8b-98eb-2448a1b34dc8
3548683435ANDAPhysicians Total Care, Inc.1994-11-22FLUOCINONIDETOPICALOINTMENT000930264ANDA073481c095ffa5-3786-44ef-9a66-e8441e39dee1
4604290907ANDAGolden State Medical Supply, Inc.1997-07-29FLUOCINONIDETOPICALOINTMENT516721264ANDA0749356557d0f0-c276-442b-a81c-57cd8fa669c3

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA072537FLUOCINONIDEG AND W LABORATORIES INC1989-02-07ANDA072537_001Fluocinonide Topical Gel
2ANDA072933FLUOCINONIDEE FOUGERA DIV ALTANA INC1994-12-30ANDA072933_001Fluocinonide Topical Gel
3ANDA073481FLUOCINONIDETEVA PHARMACEUTICALS USA INC1991-12-27ANDA073481_001
4ANDA074905FLUOCINONIDEFOUGERA PHARMACEUTICALS INC1997-08-26ANDA074905_001
5ANDA074935FLUOCINONIDETARO PHARMACEUTICALS INC1997-07-29ANDA074935_001Fluocinonide Topical Gel
6ANDA075008FLUOCINONIDETARO PHARMACEUTICALS INC1999-06-30ANDA075008_001
7NDA016909LIDEXTrueCOUNTY LINE PHARMACEUTICALS LLCNDA016909_002
8NDA017373LIDEXTrueCOUNTY LINE PHARMACEUTICALS LLCNDA017373_001Fluocinonide Topical Gel

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA072537_001RXFLUOCINONIDE (0.05%)TOPICALGELFalseAB1989-02-07FLUOCINONIDE
2ANDA072933_001RXFLUOCINONIDE (0.05%)TOPICALGELFalseAB1994-12-30FLUOCINONIDE
3ANDA073481_001RXFLUOCINONIDE (0.05%)TOPICALOINTMENTFalseAB1991-12-27FLUOCINONIDE
4ANDA074905_001RXFLUOCINONIDE (0.05%)TOPICALOINTMENTFalseAB1997-08-26FLUOCINONIDE
5ANDA074935_001RXFLUOCINONIDE (0.05%)TOPICALGELTrueAB1997-07-29FLUOCINONIDE
6ANDA075008_001RXFLUOCINONIDE (0.05%)TOPICALOINTMENTTrueAB1999-06-30FLUOCINONIDE
7NDA016909_002discontinuedFLUOCINONIDE (0.05%)TOPICALOINTMENTFalseLIDEX
8NDA017373_001discontinuedFLUOCINONIDE (0.05%)TOPICALGELFalseLIDEX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
10ae0c3dd-0413-4d8b-98eb-2448a1b34dc8 (view SPL)Fluocinonide Cream USP, 0.05% Fluocinonide Cream USP, 0.05% (Emulsified Base) Fluocinonide Gel USP, 0.05% Fluocinonide Ointment USP, 0.05%prescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-10-061545694210, 545692177Fluocinonide Topical Cream
26557d0f0-c276-442b-a81c-57cd8fa669c3 (view SPL)Fluocinonide Cream USP, 0.05% Fluocinonide Ointment USP, 0.05%Fluocinonide Solution USP, 0.05%prescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL2012-01-092604290907, 604290904, 604290908Fluocinonide Topical Solution
Fluocinonide Topical Cream
3986c1ba3-2103-4773-a35c-2c0121a01783 (view SPL)FLUOCINONIDE CREAM USP, 0.05% (Emulsified Base) FLUOCINONIDE CREAM USP, 0.05%FLUOCINONIDE OINTMENT USP, 0.05%026202630264FOR TOPICAL/EXTERNAL USE ONLYNOT FOR OPHTHALMIC USERx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-04-211000930264, 000930262, 000930263Fluocinonide Topical Cream
4b0bc89a9-c9d5-4adb-9785-2d4487c4c656 (view SPL)Fluocinonide Cream USP, 0.05% Fluocinonide Cream USP, 0.05% (Emulsified Base) Fluocinonide Gel USP, 0.05% Fluocinonide Ointment USP, 0.05%prescriptionHuman PrescriptionTaro Pharmaceuticals U.S.A., Inc.MANUFACTURE2011-07-252516721264, 516721253, 516721254, 516721279Fluocinonide Topical Cream
Fluocinonide Topical Gel
5b4b09d4a-dbe9-4f41-ac04-d4f71743722f (view SPL)FLUOCINONIDE OINTMENT USP, 0.05%FOR TOPICAL/EXTERNAL USE ONLYNOT FOR OPHTHALMIC USERx onlyprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-09-071216950979
6c095ffa5-3786-44ef-9a66-e8441e39dee1 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-09-081548683435, 548680431, 548683023Fluocinonide Topical Cream
Fluocinonide Topical Gel
7c2cf3e9b-dca2-492d-a3c1-833c4250b937 (view SPL)FLUOCINONIDE OINTMENT USP, 0.05%prescriptionHuman PrescriptionE. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.2013-07-154001680140

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