FDA.reportPublic FDA data

Application 089742

Type
ANDA
Sponsor
LANNETT

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDELannett Company, Inc.6cd6ba35-3481-48c1-87db-dc74ce9d7d752024-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (product): 0527-1790

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 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0527-1790Fluphenazine HydrochlorideFluphenazine HydrochlorideLannett Company, Inc.ANDACurrent
0527-1790Fluphenazine HydrochlorideFluphenazine HydrochlorideLannett Company, Inc.ANDACurrent
68084-846Fluphenazine HydrochlorideFluphenazine HydrochlorideAmerican Health PackagingANDACurrent
68084-846Fluphenazine HydrochlorideFluphenazine HydrochlorideAmerican Health PackagingANDACurrent
68084-846Fluphenazine HydrochlorideFluphenazine HydrochlorideAmerican Health PackagingANDACurrent
68151-2465Fluphenazine HydrochlorideFluphenazine HydrochlorideCarilion Materials ManagementANDACurrent
70518-1496Fluphenazine HydrochlorideFluphenazine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1496Fluphenazine HydrochlorideFluphenazine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1496Fluphenazine HydrochlorideFluphenazine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1496Fluphenazine HydrochlorideFluphenazine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1496Fluphenazine HydrochlorideFluphenazine HydrochlorideREMEDYREPACK INC.ANDACurrent