FDA.reportPublic FDA data

Application 020001

Type
NDA
Sponsor
GALDERMA LABS LP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CAPEXFLUOCINOLONE ACETONIDESHAMPOO;TOPICAL0.01%YesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020001-001CAPEXFLUOCINOLONE ACETONIDE0.01%SHAMPOO / TOPICALRLD1990-08-27

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09N020001-001CAPEX0.01%SHAMPOO / TOPICALRLD, RS1990-08-27e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020001-001CAPEX0.01%SHAMPOO / TOPICALRLD, RS1990-08-27cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020001-001CAPEX0.01%SHAMPOO / TOPICALRLD1990-08-27a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 3 · 42 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluocinolone AcetonideFLUOCINOLONE ACETONIDEBryant Ranch Prepack30b0013a-d289-4230-8f50-0a0ff05f4b5e2026-06-18Adverse reactionsName fallback
generic name: FLUOCINOLONE ACETONIDE
Derma-Smoothe/FSFLUOCINOLONE ACETONIDERoyal Pharmaceuticals, LLCbc61c619-a71c-46f5-80f1-9e9ee71134aa2026-06-09Warnings, Adverse reactionsName fallback
generic name: FLUOCINOLONE ACETONIDE
DERMA-SMOOTHE/FSFLUOCINOLONE ACETONIDERoyal Pharmaceuticals113e167a-a9fe-440e-9446-d6d87963ef462026-06-09Warnings, Adverse reactionsName fallback
generic name: FLUOCINOLONE ACETONIDE
fluocinolone acetonideFLUOCINOLONE ACETONIDEBryant Ranch Prepack4790bdfa-c964-4c3e-9d01-c2fb23a0172e2026-05-26Warnings, Adverse reactionsName fallback
generic name: FLUOCINOLONE ACETONIDE
Fluocinolone acetonideFLUOCINOLONE ACETONIDEA-S Medication Solutions09284ede-6be9-4192-b178-567b3c6265bb2026-05-08Warnings, Adverse reactionsName fallback
generic name: FLUOCINOLONE ACETONIDE
RetisertFLUOCINOLONE ACETONIDEBausch & Lomb Incorporated1ab0f849-2a0d-47ce-ad05-768094da8cc92026-03-31Warnings, Adverse reactionsName fallback
generic name: FLUOCINOLONE ACETONIDE
Fluocinolone Acetonide OilFLUOCINOLONE ACETONIDERising Pharma Holdings, Inc.79591576-1eab-48c5-b0a6-e205b3cc097e2026-03-09Warnings, Adverse reactionsName fallback
generic name: FLUOCINOLONE ACETONIDE
Fluocinolone Acetonide OilFLUOCINOLONE ACETONIDERising Pharma Holdings, Inc.f45b0ef2-1702-4d21-8ac8-7747693045952026-03-09Warnings, Adverse reactionsName fallback
generic name: FLUOCINOLONE ACETONIDE
fluocinolone acetonideFLUOCINOLONE ACETONIDEANI Pharmaceuticals, Inc.50e7006d-a51b-49aa-8e1c-330340e7bf822026-02-23Adverse reactionsName fallback
generic name: FLUOCINOLONE ACETONIDE
Fluocinolone AcetonideFLUOCINOLONE ACETONIDEANI Pharmaceuticals, Inc.622c9804-0be0-4dec-a6ba-5cf4b5578a842026-02-23Adverse reactionsName fallback
generic name: FLUOCINOLONE ACETONIDE
YUTIQFLUOCINOLONE ACETONIDEANI Pharmaceuticals, Inc.f270cad8-ed82-4969-b785-831a1910bfa62026-02-19Warnings, Adverse reactionsName fallback
generic name: FLUOCINOLONE ACETONIDE
Fluocinolone AcetonideFLUOCINOLONE ACETONIDEE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC49552e29-7813-4726-b15d-63bd975b65882026-01-28Adverse reactionsName fallback
generic name: FLUOCINOLONE ACETONIDE
IluvienFLUOCINOLONE ACETONIDEANI Pharmaceuticals, Inc.4400e471-7402-11df-93f2-0800200c9a662026-01-28Warnings, Adverse reactionsName fallback
generic name: FLUOCINOLONE ACETONIDE
Fluocinolone AcetonideFLUOCINOLONE ACETONIDEFougera Pharmaceuticals, LLC5649e15a-6a7c-4752-ac28-01e453afb37e2026-01-28Adverse reactionsName fallback
generic name: FLUOCINOLONE ACETONIDE
FLUOCINOLONE ACETONIDE OilFLUOCINOLONE ACETONIDERISING PHARMA HOLDINGS, INC.f4a58ecc-cd50-4414-add1-a82b09da20582026-01-22Warnings, Adverse reactionsName fallback
generic name: FLUOCINOLONE ACETONIDE
FLUOCINOLONE ACETONIDEFLUOCINOLONE ACETONIDEBryant Ranch Prepackf7861aba-f199-4fe4-90cc-bebea55b3b5f2025-11-11Adverse reactionsName fallback
generic name: FLUOCINOLONE ACETONIDE
Fluocinolone AcetonideFLUOCINOLONE ACETONIDEBryant Ranch Prepack1539d6ac-b527-4ff0-afe4-083ceac655f32025-11-11Adverse reactionsName fallback
generic name: FLUOCINOLONE ACETONIDE
Fluocinolone AcetonideFLUOCINOLONE ACETONIDEBryant Ranch Prepack8b6cbb2e-9c9a-4bef-bf06-f62bdbed8c8b2025-11-10Warnings, Adverse reactionsName fallback
generic name: FLUOCINOLONE ACETONIDE
Fluocinolone acetonideFLUOCINOLONE ACETONIDEBryant Ranch Prepackf674a0c0-df04-47e8-8d3f-a370182a596a2025-10-29Adverse reactionsName fallback
generic name: FLUOCINOLONE ACETONIDE
Fluocinolone AcetonideFLUOCINOLONE ACETONIDESun Pharmaceutical Industries, Inc.b6796a10-9c90-429d-bfd6-33b557dc952c2025-09-02Warnings, Adverse reactionsName fallback
generic name: FLUOCINOLONE ACETONIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0299-5500Capexfluocinolone acetonideGalderma Laboratories, L.P.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
19925SUPPL2015-12-18