Application 080472

Type
ANDA
Sponsor
VALEANT INTL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
003HYTONEHYDROCORTISONECREAM;TOPICAL1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo
004HYTONEHYDROCORTISONECREAM;TOPICAL2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A080472-003HYTONEHYDROCORTISONE1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 1982
A080472-004HYTONEHYDROCORTISONE2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 1982

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 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A080472-003HYTONE1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A080472-004HYTONE2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080472-003HYTONE1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080472-004HYTONE2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A080472-003HYTONE1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A080472-004HYTONE2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080472-003HYTONE1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080472-004HYTONE2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080472-003HYTONE1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080472-004HYTONE2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080472-003HYTONE1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080472-004HYTONE2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080472-003HYTONE1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080472-004HYTONE2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080472-003HYTONE1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080472-004HYTONE2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080472-003HYTONE1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080472-004HYTONE2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A080472-003HYTONE1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A080472-004HYTONE2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080472-003HYTONE1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080472-004HYTONE2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A080472-003HYTONE1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A080472-004HYTONE2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A080472-003HYTONE1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A080472-004HYTONE2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A080472-003HYTONE1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05A080472-004HYTONE2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A080472-003HYTONE1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A080472-004HYTONE2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A080472-003HYTONE1%CREAM / TOPICALRLD, Approved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A080472-004HYTONE2.5%CREAM / TOPICALRLD, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A080472-003HYTONE1%CREAM / TOPICALRLD, Approved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A080472-004HYTONE2.5%CREAM / TOPICALRLD, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A080472-003HYTONE1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**CREAM / TOPICALApproved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A080472-004HYTONE2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**CREAM / TOPICALApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A080472-003HYTONE1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A080472-004HYTONE2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A080472-003HYTONE1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**CREAM / TOPICALRLD, Approved before 1982782e0a99824c…
2021-12-28 21:50 UTC2021-12A080472-004HYTONE2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**CREAM / TOPICALRLD, Approved before 1982782e0a99824c…

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 19 · 368 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
hydrocortisoneHYDROCORTISONEEywa Pharma Incb3f06d10-2f01-428c-88a4-505c61c87ce82026-07-25Warnings, Adverse reactionsName fallback
generic name: HYDROCORTISONE
AEROSOOTHEHYDROCORTISONEAero Healthcare US LLC22b172a2-07e8-4ebb-b0a0-dfe4f25477fa2026-07-24WarningsName fallback
generic name: HYDROCORTISONE
Barmicil PlusHYDROCORTISONEOPMX LLC5763b4de-06f2-7b19-e063-6294a90ad0682026-07-24WarningsName fallback
generic name: HYDROCORTISONE
HydrocortisoneHYDROCORTISONEAKRON PHARMA INCdaad9a1e-98d2-4ce7-9d97-ac5d81905abb2026-07-22WarningsName fallback
generic name: HYDROCORTISONE
LYEON Anti-itch CreamHYDROCORTISONEGuangzhou Xinhongda Trading Service Co., Ltd.56b773ce-167f-7873-e063-6394a90a98162026-07-16WarningsName fallback
generic name: HYDROCORTISONE
Barmicil PlusHYDROCORTISONEOPMX LLC5698207f-9223-f3a6-e063-6294a90a8ab62026-07-14WarningsName fallback
generic name: HYDROCORTISONE
Quadriderm NFHYDROCORTISONEOPMX LLC5643f850-e0d4-d8d8-e063-6294a90a42602026-07-10WarningsName fallback
generic name: HYDROCORTISONE
Drs. Hydrocortisone Aloe VeraHYDROCORTISONEOL PHARMA TECH,LLC0df06415-5d32-7ef8-e063-6294a90a6e5a2026-07-09WarningsName fallback
generic name: HYDROCORTISONE
Ala-ScalpHYDROCORTISONEDerm Ventures LLC61498a40-3b3c-4066-89c8-d99686e2d6382026-07-08Warnings, Adverse reactionsName fallback
generic name: HYDROCORTISONE
DIPROSPANHYDROCORTISONEOPMX LLC55fa9ecb-b843-5748-e063-6294a90a2d532026-07-06WarningsName fallback
generic name: HYDROCORTISONE
CVS No Mess CortisoneHYDROCORTISONENatural Essentials, Inc.558c94ec-95f1-eb98-e063-6394a90a1e722026-07-01WarningsName fallback
generic name: HYDROCORTISONE
HydrocortisoneHYDROCORTISONEEncube Ethicals, Inc.11e120e2-a1ca-477c-b474-bcbb726567052026-06-26Adverse reactionsName fallback
generic name: HYDROCORTISONE
Medi-First Hydrocortisone 1 % Anti-Itch CreamHYDROCORTISONEUnifirst First Aid Corporation49f04e5d-746d-cbe9-e063-6294a90a7e882026-06-16WarningsName fallback
generic name: HYDROCORTISONE
HydroxymHYDROCORTISONEPureTek Corporationfebffc84-e65e-e811-e053-6294a90a0ad12026-06-15Warnings, Adverse reactionsName fallback
generic name: HYDROCORTISONE
Hydrocortisone 1% Anti-ItchCreamHYDROCORTISONEAcme United Corporation5425fc2b-4f25-3e64-e063-6394a90aff492026-06-13WarningsName fallback
generic name: HYDROCORTISONE
good sense anti itchHYDROCORTISONEPreferred Pharmaceuticals Inc.e51047da-8e17-4dd7-be3c-54820a7485f22026-06-09WarningsName fallback
generic name: HYDROCORTISONE
Walgreens Scalp Itch ReliefHYDROCORTISONEWalgreens34952272-1f9e-c642-e063-6394a90ae2bd2026-05-29WarningsName fallback
generic name: HYDROCORTISONE
HydrocortisoneHYDROCORTISONEMylan Pharmaceuticals Inc.bc751403-94f2-4f9d-b533-cf6186a40ceb2026-05-25Warnings, Adverse reactionsName fallback
generic name: HYDROCORTISONE
topcare hydrocortisoneHYDROCORTISONETopco Associates LLC858053a0-d888-4bb9-b94e-503bcf3864cb2026-05-21WarningsName fallback
generic name: HYDROCORTISONE
HydrocortisoneHYDROCORTISONEBryant Ranch Prepack04758c46-0ca4-4852-acdc-1f8553ce2e6e2026-05-21Adverse reactionsName fallback
generic name: HYDROCORTISONE