fluocinolone Topical Solution

Brand(s)
Synalar
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Medimetriks Pharmaceuticals Inc (2013-01-04)
Oldest Current Product
1982-12-16
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
TOPICAL SOLUTION\FLUOCINOLONE
FDAOB
TOPICAL\SOLUTION\FLUOCINOLONE ACETONIDE
SPL Active
TOPICAL\SOLUTION\FLUOCINOLONE ACETONIDE
SPL Moiety
TOPICAL\SOLUTION\FLUOCINOLONE ACETONIDE

product(s) by strength(s)

fluocinolone acetonide 0.1 mg/ml topical solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1435380920SynalarNDAMedimetriks Pharmaceuticals Inc2012-05-31, 2012-08-15FLUOCINOLONE ACETONIDETOPICALSOLUTIONNDA0152964feecef4-553f-4a90-a3ce-a19eb04bd68e, b48f3e2f-f92d-41b1-8e99-08f0b72c4672

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001680059ANDAE. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.1982-12-16FLUOCINOLONE ACETONIDETOPICALSOLUTIONANDA0881675649e15a-6a7c-4752-ac28-01e453afb37e
2433860069ANDAGavis Pharmaceuticals, Llc2015-09-02FLUOCINOLONE ACETONIDETOPICALSOLUTIONANDA206422460f5a55-6437-4651-bc08-8063ca579c8d
3516721365ANDATaro Pharmaceuticals U.S.A., Inc.2015-03-27FLUOCINOLONE ACETONIDETOPICALSOLUTIONANDA08912402352ed1-3568-441f-add8-45201351a11c
4525650012NDA AUTHORIZED GENERICIgi Labs, Inc.2012-11-27FLUOCINOLONE ACETONIDETOPICALSOLUTIONNDA015296b859bc63-a9e3-4a6d-a3f7-711b4eeaba63

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548682264ANDAPhysicians Total Care, Inc.1996-04-03FLUOCINOLONE ACETONIDETOPICALSOLUTION001680059ANDA088167372a6a06-c9de-48d5-ad02-c4004038f85e

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040059FLUOCINOLONE ACETONIDETrueBAUSCH AND LOMB PHARMACEUTICALS INC1993-12-20ANDA040059_001
2ANDA087158FLUONIDTrueALLERGAN HERBERT DIV ALLERGAN INC1983-03-17ANDA087158_001
3ANDA087159FLUOCINOLONE ACETONIDETrueALPHARMA US PHARMACEUTICALS DIVISION1982-06-16ANDA087159_001
4ANDA088048FLUOCINOLONE ACETONIDETruePHARMADERM DIV ALTANA INC1982-12-16ANDA088048_001
5ANDA088167FLUOCINOLONE ACETONIDEE FOUGERA DIV ALTANA INC1982-12-16ANDA088167_001
6ANDA088171FLUOTREXTrueSAVAGE LABORATORIES INC DIV ALTANA INC1983-03-09ANDA088171_001
7ANDA088312FLUOCINOLONE ACETONIDETrueMORTON GROVE PHARMACEUTICALS INC1984-01-27ANDA088312_001
8ANDA088449FLUOCINOLONE ACETONIDETruePHARMAFAIR INC1984-02-08ANDA088449_001
9ANDA089124FLUOCINOLONE ACETONIDETARO PHARMACEUTICALS USA INC1985-09-11ANDA089124_001
10ANDA206422FLUOCINOLONE ACETONIDEGAVIS PHARMACEUTICALS LLC2015-09-02ANDA206422_001
11NDA015296SYNALARMEDIMETRIKS PHARMACEUTICALS INCNDA015296_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040059_001discontinuedFLUOCINOLONE ACETONIDE (0.01%)TOPICALSOLUTIONFalse1993-12-20FLUOCINOLONE ACETONIDE
2ANDA087158_001discontinuedFLUOCINOLONE ACETONIDE (0.01%)TOPICALSOLUTIONFalse1983-03-17FLUONID
3ANDA087159_001discontinuedFLUOCINOLONE ACETONIDE (0.01%)TOPICALSOLUTIONFalse1982-06-16FLUOCINOLONE ACETONIDE
4ANDA088048_001discontinuedFLUOCINOLONE ACETONIDE (0.01%)TOPICALSOLUTIONFalse1982-12-16FLUOCINOLONE ACETONIDE
5ANDA088167_001RXFLUOCINOLONE ACETONIDE (0.01%)TOPICALSOLUTIONFalseAT1982-12-16FLUOCINOLONE ACETONIDE
6ANDA088171_001discontinuedFLUOCINOLONE ACETONIDE (0.01%)TOPICALSOLUTIONFalse1983-03-09FLUOTREX
7ANDA088312_001discontinuedFLUOCINOLONE ACETONIDE (0.01%)TOPICALSOLUTIONFalse1984-01-27FLUOCINOLONE ACETONIDE
8ANDA088449_001discontinuedFLUOCINOLONE ACETONIDE (0.01%)TOPICALSOLUTIONFalse1984-02-08FLUOCINOLONE ACETONIDE
9ANDA089124_001RXFLUOCINOLONE ACETONIDE (0.01%)TOPICALSOLUTIONFalseAT1985-09-11FLUOCINOLONE ACETONIDE
10ANDA206422_001RXFLUOCINOLONE ACETONIDE (0.01%)TOPICALSOLUTIONFalseAT2015-09-02FLUOCINOLONE ACETONIDE
11NDA015296_001RXFLUOCINOLONE ACETONIDE (0.01%)TOPICALSOLUTIONTrueATSYNALAR

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
102352ed1-3568-441f-add8-45201351a11c (view SPL)Fluocinolone Acetonide Topical Solution USP, 0.01%prescriptionHuman PrescriptionTaro Pharmaceuticals U.S.A., Inc.MANUFACTURE2015-01-261516721365
2372a6a06-c9de-48d5-ad02-c4004038f85e (view SPL)FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01%prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2009-11-101548682264
3460f5a55-6437-4651-bc08-8063ca579c8d (view SPL)Fluocinolone Acetonide Topical Solution USP, 0.01% Rx OnlyprescriptionHuman PrescriptionGavis Pharmaceuticals, LlcANALYSIS, MANUFACTURE2015-09-102433860069
44feecef4-553f-4a90-a3ce-a19eb04bd68e (view SPL)SYNALAR (fluocinolone acetonide)Topical Solution 0.01%prescriptionHuman PrescriptionMedimetriks Pharmaceuticals IncMANUFACTURE2012-09-051435380920, 435380921
55649e15a-6a7c-4752-ac28-01e453afb37e (view SPL)FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01%prescriptionHuman PrescriptionE. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.2013-03-076001680059
6b48f3e2f-f92d-41b1-8e99-08f0b72c4672 (view SPL)SYNALAR (fluocinolone acetonide)Topical Solution, 0.01%prescriptionHuman PrescriptionMedimetriks Pharmaceuticals IncMANUFACTURE2013-01-044435380920, 435380921
7b859bc63-a9e3-4a6d-a3f7-711b4eeaba63 (view SPL)Fluocinolone Acetonide Topical Solution USP, 0.01%prescriptionHuman PrescriptionIgi Labs, Inc.manufacture2012-12-073525650012

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