Application 089893

Type
ANDA
Sponsor
QUAD PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRIFLUOPERAZINE HCLTRIFLUOPERAZINE HYDROCHLORIDEInjectable; InjectionEQ 2MG BASE/MLNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 ยท 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trifluoperazine HydrochlorideTRIFLUOPERAZINE HYDROCHLORIDEREMEDYREPACK INC.f789e8f4-7ed2-4cac-b1b1-5068690cd0ed2026-06-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TRIFLUOPERAZINE HYDROCHLORIDE
Trifluoperazine HydrochlorideTRIFLUOPERAZINE HYDROCHLORIDESafecor Health LLC8501543b-0c74-4087-9946-e7198400814a2026-05-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TRIFLUOPERAZINE HYDROCHLORIDE
Trifluoperazine HydrochlorideTRIFLUOPERAZINE HYDROCHLORIDEREMEDYREPACK INC.339ceb53-3b1c-459f-84eb-77bd4315c9982026-01-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TRIFLUOPERAZINE HYDROCHLORIDE
Trifluoperazine HydrochlorideTRIFLUOPERAZINE HYDROCHLORIDEREMEDYREPACK INC.6a05900b-ca43-483a-a460-8ac378653f122026-01-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TRIFLUOPERAZINE HYDROCHLORIDE
Trifluoperazine HydrochlorideTRIFLUOPERAZINE HYDROCHLORIDEMylan Institutional Inc.f742a579-411a-4140-91c4-edc735d638fa2025-07-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TRIFLUOPERAZINE HYDROCHLORIDE
Trifluoperazine HydrochlorideTRIFLUOPERAZINE HYDROCHLORIDEMylan Pharmaceuticals Inc.c2575a86-19e5-44df-8603-ff066bb9c9c52025-01-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TRIFLUOPERAZINE HYDROCHLORIDE
Trifluoperazine HydrochlorideTRIFLUOPERAZINE HYDROCHLORIDESandoz Inc.ae43c10e-cfa9-4298-8af5-7a3e6524bbda2024-11-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TRIFLUOPERAZINE HYDROCHLORIDE
Trifluoperazine HydrochlorideTRIFLUOPERAZINE HYDROCHLORIDEBryant Ranch Prepacke63617bb-8186-43d3-9d01-aa53217343e42024-10-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TRIFLUOPERAZINE HYDROCHLORIDE
Trifluoperazine HydrochlorideTRIFLUOPERAZINE HYDROCHLORIDEBryant Ranch Prepack19b76401-6790-44f7-b756-b078948bbf122024-04-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TRIFLUOPERAZINE HYDROCHLORIDE
Trifluoperazine HydrochlorideTRIFLUOPERAZINE HYDROCHLORIDEBryant Ranch Prepack7be0a6fa-a2a0-4f9d-94ca-47ab51de9c1d2024-04-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TRIFLUOPERAZINE HYDROCHLORIDE
Trifluoperazine HydrochlorideTRIFLUOPERAZINE HYDROCHLORIDEBryant Ranch Prepackdf3e0bef-1032-405d-bd18-f65c27af94eb2024-04-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TRIFLUOPERAZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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