FDA.reportPublic FDA data

Application 078214

Type
ANDA
Sponsor
LANNETT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DANAZOLDANAZOLCAPSULE;ORAL50MGNoNo
002DANAZOLDANAZOLCAPSULE;ORAL100MGNoNo

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DanazolDANAZOLProficient Rx LP9e103cf9-f075-48ba-8913-2e44f94427812022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078214
application number: ANDA078214
ndc (product): 71205-861
DanazolDANAZOLLannett Company, Inc.f2c9b713-aafc-49ca-866e-334d9b5c2e2d2020-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078214
application number: ANDA078214
ndc (product): 0527-1392
ndc (product): 0527-1368

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0527-1368DanazolDanazolLannett Company, Inc.ANDACurrent
0527-1368DanazolDanazolLannett Company, Inc.ANDACurrent
0527-1368DanazolDanazolLannett Company, Inc.ANDACurrent
0527-1368DanazolDanazolLannett Company, Inc.ANDACurrent
0527-1392DanazolDanazolLannett Company, Inc.ANDACurrent
0527-1392DanazolDanazolLannett Company, Inc.ANDACurrent
0527-1392DanazolDanazolLannett Company, Inc.ANDACurrent
0527-1392DanazolDanazolLannett Company, Inc.ANDACurrent
71205-861DanazolDanazolProficient Rx LPANDACurrent