FDA.reportPublic FDA data

Application 018795

Type
NDA
Sponsor
YAMANOUCHI

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LOCOIDHYDROCORTISONE BUTYRATECREAM;TOPICAL0.1%NoNo

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
N018795-001LOCOIDHYDROCORTISONE BUTYRATE0.1%CREAM / TOPICAL1983-01-07

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 UTC2022-10N018795-001LOCOID0.1%CREAM / TOPICAL1983-01-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018795-001LOCOID0.1%CREAM / TOPICAL1983-01-07e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018795-001LOCOID0.1%CREAM / TOPICAL1983-01-07cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N018795-001LOCOID0.1%CREAM / TOPICAL1983-01-07a50c72e98297…

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 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocortisone ButyrateHYDROCORTISONE BUTYRATESun Pharmaceutical Industries, Inc.51176835-598d-4da7-8a00-6bd36f52aa822026-07-14Adverse reactionsName fallback
generic name: HYDROCORTISONE BUTYRATE
EvesseHYDROCORTISONE BUTYRATEPerfero Pharma, Inc.988b5524-2947-4862-9d5b-e8b7fec5fd9a2026-05-14Warnings, Adverse reactionsName fallback
generic name: HYDROCORTISONE BUTYRATE
Hydrocortisone ButyrateHYDROCORTISONE BUTYRATEBryant Ranch Prepackce135638-e551-4bb0-bd2b-f97d381a8c7c2026-04-23Warnings, Adverse reactionsName fallback
generic name: HYDROCORTISONE BUTYRATE
Hydrocortisone ButyrateHYDROCORTISONE BUTYRATELupin Pharmaceuticals, Inc.275f3fcf-1170-4df0-9a8d-1482bda409cb2025-10-13Warnings, Adverse reactionsName fallback
generic name: HYDROCORTISONE BUTYRATE
Hydrocortisone ButyrateHYDROCORTISONE BUTYRATEThe J. Molner Company LLC160c463e-80d2-4bca-8b7f-42279617e3092025-10-06Warnings, Adverse reactionsName fallback
generic name: HYDROCORTISONE BUTYRATE
Hydrocortisone ButyrateHYDROCORTISONE BUTYRATEOceanside Pharmaceuticalsddf699f4-1ae0-48c3-8d2a-56aa1a2c5bc12025-06-05Warnings, Adverse reactionsName fallback
generic name: HYDROCORTISONE BUTYRATE
Hydrocortisone ButyrateHYDROCORTISONE BUTYRATEOceanside Pharmaceuticals7c3f8417-7861-41e3-876f-9b82aff7d1a02020-12-31Adverse reactionsName fallback
generic name: HYDROCORTISONE BUTYRATE

Reported adverse events (FAERS/openFDA)#

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