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 44.

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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A074795-001FLUPHENAZINE DECANOATE25MG/MLINJECTABLE / INJECTION1996-09-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074795-001FLUPHENAZINE DECANOATE25MG/MLINJECTABLE / INJECTION1996-09-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074795-001FLUPHENAZINE DECANOATE25MG/MLINJECTABLE / INJECTION1996-09-10cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A074795-001FLUPHENAZINE DECANOATE25MG/MLINJECTABLE / INJECTION1996-09-10a50c72e98297…

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluphenazine DecanoateFLUPHENAZINE DECANOATEPar Health USA, LLC970e6fde-9cc8-475b-8a9e-bde0579a72a72026-08-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Decanoate
generic name: FLUPHENAZINE DECANOATE
Fluphenazine DecanoateFLUPHENAZINE DECANOATEPar Health USA, LLCb580471f-44a1-4da0-96ad-2f537eabec3e2026-08-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Decanoate
generic name: FLUPHENAZINE DECANOATE
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

Reported adverse events (FAERS/openFDA)#

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

Documents#

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