FDA.reportPublic FDA data

Application 019322

Type
NDA
Sponsor
FOUGERA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TEMOVATECLOBETASOL PROPIONATECREAM;TOPICAL0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N019322-001TEMOVATECLOBETASOL PROPIONATE0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD1985-12-27

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N019322-001TEMOVATE0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD1985-12-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019322-001TEMOVATE0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD1985-12-27e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N019322-001TEMOVATE0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD1985-12-27cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N019322-001TEMOVATE0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD1985-12-27a50c72e98297…

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 5 · 93 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLOBETASOL PROPIONATECLOBETASOL PROPIONATEAlembic Pharmaceuticals Inc.a83d212b-a970-4ee7-8431-fead6b2e7f9d2026-07-17Warnings, Adverse reactionsName fallback
generic name: CLOBETASOL PROPIONATE
Clobetasol PropionateCLOBETASOL PROPIONATEAvKAREa86241e0-3187-e468-e053-2995a90a1ae52026-07-15Adverse reactionsName fallback
generic name: CLOBETASOL PROPIONATE
Clobetasol PropionateCLOBETASOL PROPIONATESun Pharmaceutical Industries, Inc.d8f560c8-e223-46f0-8afb-b418f2b6399c2026-07-14Warnings, Adverse reactionsName fallback
generic name: CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATECLOBETASOL PROPIONATEAlembic Pharmaceuticals Inc.91e7bf57-d236-4b9b-8241-e71e5e93617a2026-07-09Warnings, Adverse reactionsName fallback
generic name: CLOBETASOL PROPIONATE
Clobetasol PropionateCLOBETASOL PROPIONATEA-S Medication Solutions446209ba-61ad-46b5-99f7-039ae7fca7572026-07-06Adverse reactionsName fallback
generic name: CLOBETASOL PROPIONATE
Clobetasol PropionateCLOBETASOL PROPIONATEA-S Medication Solutions8da21ad7-4d2d-4168-82ee-ebf13ce5e9232026-06-23Adverse reactionsName fallback
generic name: CLOBETASOL PROPIONATE
Clobetasol PropionateCLOBETASOL PROPIONATEAmneal Pharmaceuticals NY LLC4363539b-d25e-4da3-911c-9ba142d7f4f42026-06-19Warnings, Adverse reactionsName fallback
generic name: CLOBETASOL PROPIONATE
Clobetasol PropionateCLOBETASOL PROPIONATETorrent Pharmaceuticals Limited6f930298-e410-4bfb-8c3f-456a1f55f4a92026-05-08Adverse reactionsName fallback
generic name: CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATECLOBETASOL PROPIONATEGolden State Medical Supply, Inc.04180cdf-c63a-d524-e063-6394a90a2d062026-04-23Adverse reactionsName fallback
generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate (emollient)CLOBETASOL PROPIONATEBryant Ranch Prepackcb0bc057-d6ab-4eea-af7a-01661ae9b5172026-04-23Warnings, Adverse reactionsName fallback
generic name: CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATECLOBETASOL PROPIONATEEncube Ethicals, Inc.8ad5f9b0-b50a-4d1f-a0c1-704b5b72bf652026-04-21Adverse reactionsName fallback
generic name: CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATECLOBETASOL PROPIONATEA-S Medication Solutionsc26e6e8f-9670-48c5-917b-e73e5589579a2026-04-14Adverse reactionsName fallback
generic name: CLOBETASOL PROPIONATE
Clobetasol PropionateCLOBETASOL PROPIONATESun Pharmaceutical Industries, Inc.4a761afb-a48a-4a5a-8700-ad93601a260f2026-03-23Adverse reactionsName fallback
generic name: CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATECLOBETASOL PROPIONATEMicro Labs Limited85aea21d-c4ff-4558-b416-516fa93bea1f2026-03-16Adverse reactionsName fallback
generic name: CLOBETASOL PROPIONATE
Clobetasol PropionateCLOBETASOL PROPIONATENorthStar RxLLC3d14fff7-f1af-4d15-96b4-88cfccad271f2026-02-11Adverse reactionsName fallback
generic name: CLOBETASOL PROPIONATE
clobetasol propionateCLOBETASOL PROPIONATEGlenmark Pharmaceuticals Inc., USA6a3ad15e-2874-40d0-9e69-105b369c8cfc2026-01-31Warnings, Adverse reactionsName fallback
generic name: CLOBETASOL PROPIONATE
Clobetasol PropionateCLOBETASOL PROPIONATEGlenmark Pharmaceuticals Inc., USAdb8c7a36-e950-44b9-b2ff-7fede2e874072026-01-29Warnings, Adverse reactionsName fallback
generic name: CLOBETASOL PROPIONATE
Clobetasol PropionateCLOBETASOL PROPIONATEGlenmark Pharmaceutcials Inc., USA69794e0b-2a79-419e-844f-ed051be622492026-01-28Adverse reactionsName fallback
generic name: CLOBETASOL PROPIONATE
Clobetasol PropionateCLOBETASOL PROPIONATEE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC736325f3-a369-4d70-b608-3d6ba37b6a6b2026-01-28Adverse reactionsName fallback
generic name: CLOBETASOL PROPIONATE
BYQLOVICLOBETASOL PROPIONATEHarrow Eye, LLC31ca5a0f-812e-491d-aa00-d8ed424ba3222026-01-26Warnings, Adverse reactionsName fallback
generic name: CLOBETASOL PROPIONATE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57632ORIG2019-02-15
40896SUPPL2003-08-05
1284SUPPL2003-04-18
11476SUPPL2003-04-07