FDA.reportPublic FDA data

Application 088322

Type
ANDA
Sponsor
PAR PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001THIORIDAZINE HYDROCHLORIDETHIORIDAZINE HYDROCHLORIDETABLET;ORAL50MGNoNo

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
A088322-001THIORIDAZINE HYDROCHLORIDETHIORIDAZINE HYDROCHLORIDE50MGTABLET / ORAL1983-12-05

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A088322-001THIORIDAZINE HYDROCHLORIDE50MGTABLET / ORAL1983-12-05e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A088322-001THIORIDAZINE HYDROCHLORIDE50MGTABLET / ORAL1983-12-05cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A088322-001THIORIDAZINE HYDROCHLORIDE50MGTABLET / ORAL1983-12-05a50c72e98297…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Thioridazine HydrochlorideTHIORIDAZINE HYDROCHLORIDESafecor Health LLC1fd16a99-e856-4a37-9dae-c443714fac142026-03-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Thioridazine Hydrochloride
generic name: THIORIDAZINE HYDROCHLORIDE
Thioridazine HydrochlorideTHIORIDAZINE HYDROCHLORIDEMylan Institutional Inc.52fea941-0b47-41c1-b00d-f88150e8ab932025-11-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Thioridazine Hydrochloride
generic name: THIORIDAZINE HYDROCHLORIDE
Thioridazine HydrochlorideTHIORIDAZINE HYDROCHLORIDEChartwell RX, LLCe0bbe982-6434-468b-bd29-64ac57386fbe2025-02-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Thioridazine Hydrochloride
generic name: THIORIDAZINE HYDROCHLORIDE
Thioridazine HydrochlorideTHIORIDAZINE HYDROCHLORIDEMylan Pharmaceuticals Inc.56b3f4c2-52af-4947-b225-6808ae9f26f52025-01-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Thioridazine Hydrochloride
generic name: THIORIDAZINE HYDROCHLORIDE
Thioridazine HydrochlorideTHIORIDAZINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.9c4bedb4-2d59-4fcd-aad7-fce988cd96d82017-10-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Thioridazine Hydrochloride
generic name: THIORIDAZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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