FDA.reportPublic FDA data

Application 089686

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PERPHENAZINEPERPHENAZINETABLET;ORAL16MGYesNo

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 2 of 2 · 36 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
perphenazinePERPHENAZINEZydus Pharmaceuticals (USA) Inc.c209f1f6-f440-4366-8140-1d24cf0c2ce62024-11-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: perphenazine
generic name: PERPHENAZINE
perphenazinePERPHENAZINEZydus Lifesciences Limited003fe32c-a55d-4191-99fa-1013522b1b2e2024-11-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: perphenazine
generic name: PERPHENAZINE
PerphenazinePERPHENAZINEWilshire Pharmaceuticals, Inc.5e455842-4892-4795-8c9b-4109a8f307832024-11-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Perphenazine
generic name: PERPHENAZINE
PerphenazinePERPHENAZINEMacleods Pharmaceuticals Limited28f0cc81-538c-4a4b-be8d-509428fcbb9c2024-10-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Perphenazine
generic name: PERPHENAZINE
PerphenazinePERPHENAZINESandoz Incfc32500c-cc42-4f85-9cee-88f983fcbc162024-03-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Perphenazine
generic name: PERPHENAZINE
PerphenazinePERPHENAZINEBryant Ranch Prepackc644628a-76c2-40d9-b7d8-0077743713b92023-12-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Perphenazine
generic name: PERPHENAZINE
PerphenazinePERPHENAZINEBryant Ranch Prepack0e87e78e-d39c-44fc-95a0-70cdb2a919412023-12-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Perphenazine
generic name: PERPHENAZINE
PerphenazinePERPHENAZINEBryant Ranch Prepacke2f9903c-cbac-4f14-b684-f12cc7e5aa852023-12-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Perphenazine
generic name: PERPHENAZINE
PerphenazinePERPHENAZINEBryant Ranch Prepack18c20201-ad92-40ac-8f99-6048c2d32c682023-09-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Perphenazine
generic name: PERPHENAZINE
PerphenazinePERPHENAZINEBryant Ranch Prepack9ad131c1-0620-4d3c-9734-bcffd98430e22023-09-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Perphenazine
generic name: PERPHENAZINE
PerphenazinePERPHENAZINEBryant Ranch Prepack63e3a25b-a9e2-449d-8631-41f700f4cdeb2023-09-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Perphenazine
generic name: PERPHENAZINE
PerphenazinePERPHENAZINEBryant Ranch Prepack4882ec28-f516-4dc8-ab15-76cf455af7092023-03-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Perphenazine
generic name: PERPHENAZINE
PerphenazinePERPHENAZINEBryant Ranch Prepack59b1a63e-6cba-4102-a5e8-83dca540341d2023-03-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Perphenazine
generic name: PERPHENAZINE
PerphenazinePERPHENAZINEBryant Ranch Prepackb5f08bc9-79b5-4c6f-8fe4-ec2ef022ebe02023-03-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Perphenazine
generic name: PERPHENAZINE
PERPHENAZINEPERPHENAZINEProficient Rx LP96322bdc-2183-413b-b7d4-c7192ba7666c2023-02-01Boxed 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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
53808-0664PerphenazinePERPHENAZINEState of Florida DOH Central PharmacyANDACurrent
53808-0762PerphenazinePERPHENAZINEState of Florida DOH Central PharmacyANDACurrent
70518-0062PerphenazinePerphenazineREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18529SUPPL2013-12-11