FDA.reportPublic FDA data

Application 089585

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDETABLET;ORAL5MGNoNo

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 · 35 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEGolden State Medical Supply, Inc.c2c6d6a1-b4b9-506d-e053-2995a90aac232025-01-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEAvPAKe3277017-1d58-7105-e053-2995a90a92552025-01-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEAvPAKdbfd138a-e107-3f78-e053-2995a90a6d8c2025-01-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEZameer Pharmaceuticals LLCd9db3882-a7b5-435b-9d5a-a5e4ef7c25372024-12-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEUpsher-Smith Laboratories, LLCd0a090fa-f7c9-4f6d-a9a3-9838870c70492024-12-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.c4448579-3ccb-442e-8950-a219d1f01a982024-11-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEZydus Lifesciences Limited977dc369-6b6d-4ad1-9239-a46f63a764bd2024-11-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEDr. Reddys Laboratories Inc.98aeddfd-4f24-4d1a-820d-d0abc17337942024-11-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEAlembic Pharmaceuticals Inc.1991be2c-9629-4c3e-93f0-e40bcffc82b02024-11-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEAurobindo Pharma Limitede73764e7-e666-4ad3-a029-04a528dc1c9e2024-11-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDELannett Company, Inc.6cd6ba35-3481-48c1-87db-dc74ce9d7d752024-11-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEFresenius Kabi USA, LLCd571f04f-6190-42f2-932c-5a075fd978b92024-10-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDENovadoz Pharmaceuticals LLC83ce71b9-28eb-4074-b1e7-192ed254c5292024-09-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEAlembic Pharmaceuticals Limited7c29fb1f-9403-4e55-abd9-36adfb152e8e2024-07-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEProficient Rx LPbc22941e-d2e7-4165-91ea-7239c8b9882d2023-02-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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