FDA.reportPublic FDA data

Application 040360

Type
ANDA
Sponsor
PHARM ASSOC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PERPHENAZINEPERPHENAZINECONCENTRATE;ORAL16MG/5MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A040360-001PERPHENAZINEPERPHENAZINE16MG/5MLCONCENTRATE / ORAL2001-05-25

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A040360-001PERPHENAZINE16MG/5MLCONCENTRATE / ORAL2001-05-25e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040360-001PERPHENAZINE16MG/5MLCONCENTRATE / ORAL2001-05-25cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A040360-001PERPHENAZINE16MG/5MLCONCENTRATE / ORAL2001-05-25a50c72e98297…

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
PERPHENAZINEPERPHENAZINEREMEDYREPACK INC.c4150683-0772-4344-bb1c-f050b84175d62026-08-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PERPHENAZINE
generic name: PERPHENAZINE
PerphenazinePERPHENAZINEPar Health USA, LLC5fbfe9da-26e8-4705-98f3-42acd3d7b4392026-08-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Perphenazine
generic name: PERPHENAZINE
PerphenazinePERPHENAZINEREMEDYREPACK INC.9588d223-41e4-4bb2-9306-f082498404c52026-07-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Perphenazine
generic name: PERPHENAZINE
PerphenazinePERPHENAZINEREMEDYREPACK INC.cf41a02d-c881-4b40-b99c-d5b79dbd645b2026-07-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Perphenazine
generic name: PERPHENAZINE
PerphenazinePERPHENAZINEREMEDYREPACK INC.da5519cd-7b96-4468-910c-87dffdb1888e2026-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Perphenazine
generic name: PERPHENAZINE
PerphenazinePERPHENAZINEREMEDYREPACK INC.fc903628-248c-4d12-88b4-a551aeadb4d22026-06-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Perphenazine
generic name: PERPHENAZINE
PerphenazinePERPHENAZINEREMEDYREPACK INC.bb08cedf-18ab-4341-a84e-c092ff7a5c982026-05-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Perphenazine
generic name: PERPHENAZINE
perphenazinePERPHENAZINEREMEDYREPACK INC.1fc98e41-17d1-4491-87ed-ff7651422b5b2026-04-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: perphenazine
generic name: PERPHENAZINE
PerphenazinePERPHENAZINEREMEDYREPACK INC.1a216d3f-12b0-44c2-b7d3-109fee45978d2026-01-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Perphenazine
generic name: PERPHENAZINE
PerphenazinePERPHENAZINEREMEDYREPACK INC.8028ab47-a6de-4924-a4cd-9336fa90dd902026-01-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Perphenazine
generic name: PERPHENAZINE
PerphenazinePERPHENAZINEChartwell RX, LLCba5f3963-3080-48bc-806a-0aed72e2c25b2025-12-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Perphenazine
generic name: PERPHENAZINE
PerphenazinePERPHENAZINEBryant Ranch Prepackaaa1127a-393d-454a-b68a-b1f206117f3b2025-10-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Perphenazine
generic name: PERPHENAZINE
PerphenazinePERPHENAZINEBryant Ranch Prepackf6af1fc3-868d-46f3-8bbe-828375fb0fae2025-04-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Perphenazine
generic name: PERPHENAZINE
PerphenazinePERPHENAZINEBryant Ranch Prepacke2e52bd9-b9c2-4f04-af03-bdb54b48c16c2025-04-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Perphenazine
generic name: PERPHENAZINE
PerphenazinePERPHENAZINEBryant Ranch Prepackafaea32d-0dc1-4dcb-9ee2-dd2937ec030e2025-04-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Perphenazine
generic name: PERPHENAZINE
PerphenazinePERPHENAZINEBryant Ranch Prepack41758282-6848-4a47-bbf3-89edc270f7b32025-04-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Perphenazine
generic name: PERPHENAZINE
PerphenazinePERPHENAZINEActavis Pharma, Inc.bb1a3d20-1f93-48a1-9e27-4712a85617572025-03-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Perphenazine
generic name: PERPHENAZINE
perphenazinePERPHENAZINEGolden State Medical Supply, Inc.f0ea4d18-643d-7acb-e053-2a95a90a9ea72024-12-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: perphenazine
generic name: PERPHENAZINE
PERPHENAZINEPERPHENAZINERising Pharma Holdings, Inc.0ebf4c11-1810-42f6-a8e3-071616e33d5d2024-12-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PERPHENAZINE
generic name: PERPHENAZINE
PERPHENAZINEPERPHENAZINEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.935a7567-0395-4901-960c-79587fa14c8d2024-11-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PERPHENAZINE
generic name: PERPHENAZINE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
7636ORIG2001-05-25