FDA.reportPublic FDA data

Application 016932

Type
NDA
Sponsor
SCHERING

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VALISONEBETAMETHASONE VALERATELOTION;TOPICALEQ 0.1% BASENoNo

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
N016932-001VALISONEBETAMETHASONE VALERATEEQ 0.1% BASELOTION / TOPICALApproved 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 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 UTC2022-10N016932-001VALISONEEQ 0.1% BASELOTION / TOPICALApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N016932-001VALISONEEQ 0.1% BASELOTION / TOPICALApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N016932-001VALISONEEQ 0.1% BASELOTION / TOPICALApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N016932-001VALISONEEQ 0.1% BASELOTION / TOPICALApproved before 1982a50c72e98297…

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 · 18 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Betamethasone ValerateBETAMETHASONE VALERATESun Pharmaceutical Industries, Inc.7c96b978-25ff-44c2-bc9c-30ff5e34cffb2026-03-23Warnings, Adverse reactionsName fallback
generic name: BETAMETHASONE VALERATE
Betamethasone ValerateBETAMETHASONE VALERATEPreferred Pharmaceuticals Inc.50d4763d-5a84-4c45-be06-040c4a5274702026-03-19Adverse reactionsName fallback
generic name: BETAMETHASONE VALERATE
BETAMETHASONE VALERATEBETAMETHASONE VALERATEPreferred Pharmaceuticals, Inc.bfa4b6f5-3b66-430a-af41-60e3f12982bc2026-03-19Adverse reactionsName fallback
generic name: BETAMETHASONE VALERATE
BETAMETHASONE VALERATEBETAMETHASONE VALERATEA-S Medication Solutions7281d272-5342-4738-b35c-42570459e9d42026-02-04Adverse reactionsName fallback
generic name: BETAMETHASONE VALERATE
Betamethasone ValerateBETAMETHASONE VALERATEE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC0b386ccc-a2d4-4d18-a2d7-e46ff894c6742026-01-28Adverse reactionsName fallback
generic name: BETAMETHASONE VALERATE
BETAMETHASONE VALERATEBETAMETHASONE VALERATESun Pharmaceutical Industries, Inc.3c85be0f-2731-44f1-a18e-d3852d54846f2025-10-02Adverse reactionsName fallback
generic name: BETAMETHASONE VALERATE
Betamethasone valerateBETAMETHASONE VALERATEAlembic Pharmaceuticals Limited75d70e76-023c-4a00-954d-79a697bed80f2025-09-25Adverse reactionsName fallback
generic name: BETAMETHASONE VALERATE
Betamethasone ValerateBETAMETHASONE VALERATEPreferred Pharmaceuticals Inc.985d1f62-4bff-4bf1-b7c7-96cb456ef83d2025-02-07Adverse reactionsName fallback
generic name: BETAMETHASONE VALERATE
BETAMETHASONE VALERATEBETAMETHASONE VALERATEA-S Medication Solutions02db1402-701c-483c-bfd6-8b7a543ae8ef2024-11-11Adverse reactionsName fallback
generic name: BETAMETHASONE VALERATE
Betamethasone valerateBETAMETHASONE VALERATEAlembic Pharmaceuticals Inc.3b6fa573-de04-4626-a39a-dca39def6df22024-08-23Adverse reactionsName fallback
generic name: BETAMETHASONE VALERATE
Betamethasone ValerateBETAMETHASONE VALERATENuCare Pharmaceuticals,Inc.a2154b33-0f61-49af-e053-2995a90a18102024-06-20Adverse reactionsName fallback
generic name: BETAMETHASONE VALERATE
BETAMETHASONE VALERATEBETAMETHASONE VALERATENuCare Pharmaceuticals,Inc.64badc1a-8922-c6e3-e053-2991aa0a8b1c2024-06-06Adverse reactionsName fallback
generic name: BETAMETHASONE VALERATE
Betamethasone ValerateBETAMETHASONE VALERATEPadagis Israel Pharmaceuticals Ltddc5dfd3e-7762-40c8-880e-c7db80d877492024-03-31Warnings, Adverse reactionsName fallback
generic name: BETAMETHASONE VALERATE
Betamethasone ValerateBETAMETHASONE VALERATEA-S Medication Solutionsf8711d17-de6a-45e3-8027-b650308207ed2023-12-15Adverse reactionsName fallback
generic name: BETAMETHASONE VALERATE
Betamethasone ValerateBETAMETHASONE VALERATEA-S Medication Solutionsd265d143-343f-41ec-9cb4-18d83edb772b2023-12-12Adverse reactionsName fallback
generic name: BETAMETHASONE VALERATE
Betamethasone ValerateBETAMETHASONE VALERATEProficient Rx LP036706f1-0a24-4765-9a62-820ad64934be2022-06-01Adverse reactionsName fallback
generic name: BETAMETHASONE VALERATE
Betamethasone ValerateBETAMETHASONE VALERATECosette Pharmaceuticals, Inc.784476d2-5e5c-fdba-a677-8973a777b5ef2022-05-05Adverse reactionsName fallback
generic name: BETAMETHASONE VALERATE
Betamethasone ValerateBETAMETHASONE VALERATEProficient Rx LP2a64b65b-8a49-45ea-9464-2269751c075c2021-04-01Adverse reactionsName fallback
generic name: BETAMETHASONE VALERATE

Reported adverse events (FAERS/openFDA)#

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