FDA.reportPublic FDA data

Application 210638

Type
ANDA
Sponsor
XIROMED

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLOBETASOL PROPIONATECLOBETASOL PROPIONATEAEROSOL, FOAM;TOPICAL0.05%NoNo

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
A210638-001CLOBETASOL PROPIONATECLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12025-11-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A210638-001AB1

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A210638-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12025-11-2084e616aacf4f…
2026-08-18 06:07:402026-07A210638-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12025-11-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210638-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12025-11-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210638-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12025-11-2031067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210638-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12025-11-20a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A210638-001AB1184e616aacf4f…
2026-08-18 06:07:402026-07A210638-001AB11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210638-001AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210638-001AB1131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210638-001AB11a50c72e98297…

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 6 · 107 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clobetasol PropionateCLOBETASOL PROPIONATE OINTMENT USP, 0.05%Bryant Ranch Prepack60f65ee3-b972-4e58-97fe-0c0ab14b9b482026-08-26Adverse reactionsName fallback
brand name: Clobetasol Propionate
Clobetasol PropionateCLOBETASOL PROPIONATE OINTMENT USP, 0.05%Bryant Ranch Prepack7c71c9a8-9c76-4de4-982f-42eb54b7689c2026-08-25Adverse reactionsName fallback
brand name: Clobetasol Propionate
Clobetasol PropionateCLOBETASOL PROPIONATE OINTMENT USP, 0.05%Bryant Ranch Prepack4d9b83e8-593e-4add-ac1d-c8eea25761bc2026-08-25Adverse reactionsName fallback
brand name: Clobetasol Propionate
Clobetasol PropionateCLOBETASOL PROPIONATE OINTMENT USP, 0.05%Bryant Ranch Prepackfa0e3c04-4b45-4aca-8b59-7df2ec3963e72026-08-25Adverse reactionsName fallback
brand name: Clobetasol Propionate
Clobetasol PropionateCLOBETASOL PROPIONATE OINTMENT USP, 0.05%Bryant Ranch Prepack09717dc5-eef3-4f50-a346-f91d7e86fec92026-08-25Adverse reactionsName fallback
brand name: Clobetasol Propionate
Clobetasol PropionateCLOBETASOL PROPIONATE OINTMENT USP, 0.05%Bryant Ranch Prepackd6a0f4ca-dd42-4af3-85e5-8c61c0ba6ae22026-08-07Adverse reactionsName fallback
brand name: Clobetasol Propionate
Clobetasol PropionateCLOBETASOL PROPIONATE OINTMENT USP, 0.05%Bryant Ranch Prepack032f1f4e-1f1c-409a-8fac-6449ee543caa2026-08-07Adverse reactionsName fallback
brand name: Clobetasol Propionate
Clobetasol PropionateCLOBETASOL PROPIONATE OINTMENT USP, 0.05%Bryant Ranch Prepack3dcc49e7-a4f8-44cf-9405-2786bdc910cb2026-08-06Adverse reactionsName fallback
brand name: Clobetasol Propionate
CLOBETASOL PROPIONATECLOBETASOL PROPIONATEAlembic Pharmaceuticals Inc.a83d212b-a970-4ee7-8431-fead6b2e7f9d2026-07-17Warnings, Adverse reactionsName fallback
brand name: CLOBETASOL PROPIONATE
generic name: CLOBETASOL PROPIONATE
Clobetasol PropionateCLOBETASOL PROPIONATEAvKAREa86241e0-3187-e468-e053-2995a90a1ae52026-07-15Adverse reactionsName fallback
brand name: Clobetasol Propionate
generic name: CLOBETASOL PROPIONATE
Clobetasol PropionateCLOBETASOL PROPIONATESun Pharmaceutical Industries, Inc.d8f560c8-e223-46f0-8afb-b418f2b6399c2026-07-14Warnings, Adverse reactionsName fallback
brand name: Clobetasol Propionate
generic name: CLOBETASOL PROPIONATE
Clobetasol PropionateCLOBETASOL PROPIONATE OINTMENT USP, 0.05%Encube Ethicals, Inc.1f076779-3f76-47d5-99f0-9b0b2d3f5fac2026-07-09Adverse reactionsName fallback
brand name: Clobetasol Propionate
CLOBETASOL PROPIONATECLOBETASOL PROPIONATEAlembic Pharmaceuticals Inc.91e7bf57-d236-4b9b-8241-e71e5e93617a2026-07-09Warnings, Adverse reactionsName fallback
brand name: CLOBETASOL PROPIONATE
generic name: CLOBETASOL PROPIONATE
Clobetasol PropionateCLOBETASOL PROPIONATEA-S Medication Solutions446209ba-61ad-46b5-99f7-039ae7fca7572026-07-06Adverse reactionsName fallback
brand name: Clobetasol Propionate
generic name: CLOBETASOL PROPIONATE
Clobetasol PropionateCLOBETASOL PROPIONATEA-S Medication Solutions8da21ad7-4d2d-4168-82ee-ebf13ce5e9232026-06-23Adverse reactionsName fallback
brand name: Clobetasol Propionate
generic name: CLOBETASOL PROPIONATE
Clobetasol PropionateCLOBETASOL PROPIONATEAmneal Pharmaceuticals NY LLC4363539b-d25e-4da3-911c-9ba142d7f4f42026-06-19Warnings, Adverse reactionsName fallback
brand name: Clobetasol Propionate
generic name: CLOBETASOL PROPIONATE
Clobetasol PropionateCLOBETASOL PROPIONATETorrent Pharmaceuticals Limited6f930298-e410-4bfb-8c3f-456a1f55f4a92026-05-08Adverse reactionsName fallback
brand name: Clobetasol Propionate
generic name: CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATECLOBETASOL PROPIONATEGolden State Medical Supply, Inc.04180cdf-c63a-d524-e063-6394a90a2d062026-04-23Adverse reactionsName fallback
brand name: CLOBETASOL PROPIONATE
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
brand name: CLOBETASOL PROPIONATE
generic name: CLOBETASOL PROPIONATE

Reported adverse events (FAERS/openFDA)#

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