FDA.reportPublic FDA data

Application 074795

Type
ANDA
Sponsor
TEVA PARENTERAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUPHENAZINE DECANOATEFLUPHENAZINE DECANOATEINJECTABLE;INJECTION25MG/MLNoNo

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

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
A074795-001FLUPHENAZINE DECANOATEFLUPHENAZINE DECANOATE25MG/MLINJECTABLE / INJECTION1996-09-10

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 22:54:322026-06A074795-001FLUPHENAZINE DECANOATE25MG/MLINJECTABLE / INJECTION1996-09-10a50c72e98297…

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 1 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluphenazine DecanoateFLUPHENAZINE DECANOATESagent Pharmaceuticals1842a678-c32b-4e81-998e-597fc370fb9e2026-07-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Decanoate
generic name: FLUPHENAZINE DECANOATE
Fluphenazine DecanoateFLUPHENAZINE DECANOATEBryant Ranch Prepack044f49f3-f980-4ef8-8beb-78412702cd9d2026-05-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Decanoate
generic name: FLUPHENAZINE DECANOATE
FLUPHENAZINE DECANOATEFLUPHENAZINE DECANOATEEugia US LLC1f532edc-1a2c-4221-80dd-1ac158dd3a722025-11-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: FLUPHENAZINE DECANOATE
generic name: FLUPHENAZINE DECANOATE
Fluphenazine DecanoateFLUPHENAZINE DECANOATENovadoz Pharmaceuticals LLC8d7ba627-cf3f-4b94-aee8-8b44cc9400be2025-03-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Decanoate
generic name: FLUPHENAZINE DECANOATE
Fluphenazine DecanoateFLUPHENAZINE DECANOATEHikma Pharmaceuticals USA Inc.1967dc24-f2a5-4095-baa9-a9d1c54103112025-01-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Decanoate
generic name: FLUPHENAZINE DECANOATE
fluphenazine decanoateFLUPHENAZINE DECANOATEGland Pharma Limited8caa3896-cde1-4cb1-9332-2e92bcf5c1f62024-12-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: fluphenazine decanoate
generic name: FLUPHENAZINE DECANOATE
Fluphenazine DecanoateFLUPHENAZINE DECANOATEMylan Institutional LLC3832d3d3-15ce-4d41-8431-11e9bd04cf4d2024-11-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Decanoate
generic name: FLUPHENAZINE DECANOATE
Fluphenazine DecanoateFLUPHENAZINE DECANOATEFresenius Kabi USA, LLCf8ba014e-aea0-49bc-8345-4e0a384b484e2024-10-14Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Decanoate
generic name: FLUPHENAZINE DECANOATE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42879ORIG2011-05-06