FDA.reportPublic FDA data

Application 089585

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDETABLET;ORAL5MGNoNo

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 2 · 35 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluphenazine HydrochorideFLUPHENAZINE HYDROCHLORIDEREMEDYREPACK INC.91b85b8d-4c10-4395-915e-272b81ef3b122026-07-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUPHENAZINE HYDROCHLORIDE
fluphenazine hydrochlorideFLUPHENAZINE HYDROCHLORIDECoupler LLC53864ae1-046e-f6de-e063-6294a90a13af2026-06-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: fluphenazine hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEREMEDYREPACK INC.34395a69-d3d1-4295-8d57-ae92e2cdd9922026-06-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine hydrochlorideFLUPHENAZINE HYDROCHLORIDEREMEDYREPACK INC.85720b55-3419-4e2c-95dd-22eec035d6f12026-04-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
fluphenazine hydrochlorideFLUPHENAZINE HYDROCHLORIDEAmneal Pharmaceuticals NY LLC5b443b30-5682-4cf3-9ed0-716efddbc8652026-04-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: fluphenazine hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.7036f7c6-0792-400d-a1c7-54f21b2bd4812026-03-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEGlenmark Pharmaceuticals Inc., USA4c3eea71-a7a1-4eda-9871-034ddeb83ed62026-01-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
fluphenazine hydrochlorideFLUPHENAZINE HYDROCHLORIDEChartwell RX, LLC325af2a4-2280-4236-8cf8-44f5700ba73f2025-12-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: fluphenazine hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDECamber Pharmaceuticals, Inc.4dd61338-8e4b-41c6-99d8-811a8e990c4e2025-11-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDEMarlex Pharmaceuticals, Inc.c69f07b1-660c-db03-e053-2995a90a54642025-11-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: FLUPHENAZINE HYDROCHLORIDE
generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine hydrochlorideFLUPHENAZINE HYDROCHLORIDEAjanta Pharma USA Inc.47695e20-9c0b-4a6b-ab1a-1dfaa75e96d82025-11-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine HydrochorideFLUPHENAZINE HYDROCHLORIDERising Pharma Holdings, Inc.9fd44ab9-79bb-472e-8434-c3d786b42de52025-10-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEMajor Pharmaceuticalse8d4065a-45fc-4adf-9406-2122ca131d992025-09-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEUpsher-Smith Laboratories,LLCf07bb3f1-c68c-441b-9de4-99a219f2500a2025-08-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDECoupler LLC37c9712b-95a1-fcc4-e063-6394a90aca502025-06-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEAmerican Health Packagingb6eadd59-a7d0-400e-ba1d-795b9243f77d2025-05-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDECoupler LLC325c8c34-2858-af36-e063-6394a90a78142025-04-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharmaf0a89d5d-01db-47f3-a873-33ab49c6e4f82025-02-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEANI Pharmaceuticals, Inc.6218cbd2-1f7f-40fa-92d2-5d5b0d7fa60b2025-01-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma0860b3f3-3116-40f8-bcb0-e5c47731bdc82025-01-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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