FDA.reportPublic FDA data

Application 216891

Type
ANDA
Sponsor
SANDOZ INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDETABLET;ORAL1MGNoNo
002FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDETABLET;ORAL2.5MGNoNo
003FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDETABLET;ORAL5MGNoNo
004FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDETABLET;ORAL10MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216891-001FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORAL2022-11-15
A216891-002FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORAL2022-11-15
A216891-003FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORAL2022-11-15
A216891-004FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORAL2022-11-15

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A216891-001FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORAL2022-11-15a50c72e98297…
2026-08-01 22:54:322026-06A216891-002FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORAL2022-11-15a50c72e98297…
2026-08-01 22:54:322026-06A216891-003FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORAL2022-11-15a50c72e98297…
2026-08-01 22:54:322026-06A216891-004FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORAL2022-11-15a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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