Application 080473

Type
ANDA
Sponsor
VALEANT INTL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
003HYTONEHYDROCORTISONELOTION;TOPICAL1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo
004HYTONEHYDROCORTISONELOTION;TOPICAL2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo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
A080473-003HYTONEHYDROCORTISONE1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LOTION / TOPICALRLD, Approved before 1982
A080473-004HYTONEHYDROCORTISONE2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LOTION / TOPICALRLD1982-11-30

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2026-02-19 14:30 UTC2026-02A080473-003HYTONE1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LOTION / TOPICALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A080473-004HYTONE2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LOTION / TOPICALRLD1982-11-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080473-003HYTONE1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LOTION / TOPICALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080473-004HYTONE2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LOTION / TOPICALRLD1982-11-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A080473-003HYTONE1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LOTION / TOPICALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A080473-004HYTONE2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LOTION / TOPICALRLD1982-11-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080473-003HYTONE1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LOTION / TOPICALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080473-004HYTONE2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LOTION / TOPICALRLD1982-11-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080473-003HYTONE1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LOTION / TOPICALRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080473-004HYTONE2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LOTION / TOPICALRLD1982-11-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080473-003HYTONE1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LOTION / TOPICALRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080473-004HYTONE2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LOTION / TOPICALRLD1982-11-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080473-003HYTONE1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LOTION / TOPICALRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080473-004HYTONE2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LOTION / TOPICALRLD1982-11-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080473-003HYTONE1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LOTION / TOPICALRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080473-004HYTONE2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LOTION / TOPICALRLD1982-11-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080473-003HYTONE1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LOTION / TOPICALRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080473-004HYTONE2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LOTION / TOPICALRLD1982-11-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A080473-003HYTONE1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LOTION / TOPICALRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A080473-004HYTONE2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LOTION / TOPICALRLD1982-11-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080473-003HYTONE1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LOTION / TOPICALRLD, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080473-004HYTONE2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LOTION / TOPICALRLD1982-11-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A080473-003HYTONE1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LOTION / TOPICALRLD, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A080473-004HYTONE2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LOTION / TOPICALRLD1982-11-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A080473-003HYTONE1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LOTION / TOPICALRLD, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A080473-004HYTONE2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LOTION / TOPICALRLD1982-11-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A080473-003HYTONE1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LOTION / TOPICALRLD, Approved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05A080473-004HYTONE2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LOTION / TOPICALRLD1982-11-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A080473-003HYTONE1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LOTION / TOPICALRLD, Approved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A080473-004HYTONE2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LOTION / TOPICALRLD1982-11-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A080473-003HYTONE1%LOTION / TOPICALRLD, Approved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A080473-004HYTONE2.5%LOTION / TOPICALRLD1982-11-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A080473-003HYTONE1%LOTION / TOPICALRLD, Approved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A080473-004HYTONE2.5%LOTION / TOPICALRLD1982-11-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A080473-003HYTONE1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**LOTION / TOPICALApproved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A080473-004HYTONE2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**LOTION / TOPICAL1982-11-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A080473-003HYTONE1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LOTION / TOPICALRLD, Approved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A080473-004HYTONE2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LOTION / TOPICALRLD1982-11-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A080473-003HYTONE1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**LOTION / TOPICALRLD, Approved before 1982782e0a99824c…
2021-12-28 21:50 UTC2021-12A080473-004HYTONE2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**LOTION / TOPICALRLD1982-11-30782e0a99824c…

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 2 of 19 · 368 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Scalpicin Anti-Itch Maximum StrengthHYDROCORTISONEReckitt Benckiser LLC7b1a29fa-b266-43e6-a87b-aa3c96ab40412026-05-13WarningsName fallback
generic name: HYDROCORTISONE
HydrocortisoneHYDROCORTISONEPreferred Pharmaceuticals Inc.02ab1006-c7c8-42c9-bda8-62c9d71425212026-05-11Adverse reactionsName fallback
generic name: HYDROCORTISONE
HydrocortisoneHYDROCORTISONEPreferred Pharmaceuticals, Inc.058bb2ff-ff51-4a3b-ba47-cb02272d06312026-05-11Adverse reactionsName fallback
generic name: HYDROCORTISONE
hydrocortisoneHYDROCORTISONEPreferred Pharmaceuticals Inc.12cd35e3-e707-4551-b778-bf615c1a8d322026-05-11WarningsName fallback
generic name: HYDROCORTISONE
HYDROCORTISONEHYDROCORTISONEPreferred Pharmaceuticals Inc.0bbb8a63-ae1d-41d7-b201-d1b171b31f462026-05-11Warnings, Adverse reactionsName fallback
generic name: HYDROCORTISONE
HydrocortisoneHYDROCORTISONEPreferred Pharmaceuticals, Inc.026728d4-846b-4bd4-9183-ae6c4a7141382026-05-11Adverse reactionsName fallback
generic name: HYDROCORTISONE
Harris Teeter HydrocortisoneHYDROCORTISONEHARRIS TEETER LLC4e8199f8-96ec-5342-e063-6294a90afb2d2026-05-07WarningsName fallback
generic name: HYDROCORTISONE
CAREALL Hydrocortisone Maximum StrengthHYDROCORTISONENew World Imports, Inc.5114cdba-96a1-c399-e063-6294a90aac122026-05-06WarningsName fallback
generic name: HYDROCORTISONE
hydrocortisoneHYDROCORTISONEPadagis Israel Pharmaceuticals Ltd2dc7f76f-f9ad-46ba-8b41-952e1c15f0522026-04-29WarningsName fallback
generic name: HYDROCORTISONE
anti itchHYDROCORTISONEHyVee Ince1db3641-2e83-4fec-8394-98d0d876ce0d2026-04-29WarningsName fallback
generic name: HYDROCORTISONE
FixMySkin Healing Balm Vanilla FlavorHYDROCORTISONELovely Skin, Inc.52f7a561-a0b5-4562-a588-d74fd874b83a2026-04-28WarningsName fallback
generic name: HYDROCORTISONE
HydrocortisoneHYDROCORTISONESportpharm LLCef9cf62a-5805-48bc-915e-c0e91a10837e2026-04-24Adverse reactionsName fallback
generic name: HYDROCORTISONE
HydrocortisoneHYDROCORTISONESportpharm LLC78f43570-b6fd-42eb-bb9e-580abf79bf0d2026-04-24Adverse reactionsName fallback
generic name: HYDROCORTISONE
FixMySkin Healing Balm UnflavoredHYDROCORTISONELovely Skin, Inc.9ff8db07-ad6d-4865-a534-94bd8312957e2026-04-23WarningsName fallback
generic name: HYDROCORTISONE
HydrocortisoneHYDROCORTISONEBryant Ranch Prepackc3916e9f-f783-45a2-b38b-959b12c262522026-04-22Adverse reactionsName fallback
generic name: HYDROCORTISONE
Hydrocortisone 1%HYDROCORTISONEPreferred Pharmaceuticals Inc.e0f46445-64c5-4f5d-90b0-3fa07ed7d1b42026-04-22WarningsName fallback
generic name: HYDROCORTISONE
Alkindi SprinkleHYDROCORTISONEEton Pharmaceuticals, Inc.26c13a5f-7119-4c6a-bf10-fda4e07d76822026-04-21Warnings, Adverse reactionsName fallback
generic name: HYDROCORTISONE
Anti-Itch Regular StrengthHYDROCORTISONECVS Pharmacy9fe7768b-9023-c9ee-e053-2a95a90a55b32026-04-17WarningsName fallback
generic name: HYDROCORTISONE
HydrocortisoneHYDROCORTISONEBryant Ranch Prepack2352bb58-a624-4c5e-8966-f68817c304702026-04-03Adverse reactionsName fallback
generic name: HYDROCORTISONE
HydrocortisoneHYDROCORTISONEREMEDYREPACK INC.f0e66726-946b-4f63-b457-2851dc69e6b42026-04-03Adverse reactionsName fallback
generic name: HYDROCORTISONE