FDA.reportPublic FDA data

Application 089741

Type
ANDA
Sponsor
LANNETT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDETABLET;ORAL2.5MGNoNo

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): 0527-1789

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0527-1789Fluphenazine HydrochlorideFluphenazine HydrochlorideLannett Company, Inc.ANDACurrent
0527-1789Fluphenazine HydrochlorideFluphenazine HydrochlorideLannett Company, Inc.ANDACurrent