FDA.reportPublic FDA data

Application 022432

Type
NDA
Sponsor
QUESTCOR PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001H.P. ACTHAR GELREPOSITORY CORTICOTROPININJECTABLE; INJECTION80 UNITS/MLNoNo

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
ActharREPOSITORY CORTICOTROPINMallinckrodt ARD LLC7b48ddec-e815-45f4-9ca0-5c0daaf56f302026-07-15Warnings, Adverse reactionsExact identifier
ndc (product): 63004-8710

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63004-8710ActharRepository CorticotropinMallinckrodt ARD LLCNDACurrent
63004-8710ActharRepository CorticotropinMallinckrodt ARD LLCNDACurrent
63004-8710ActharRepository CorticotropinMallinckrodt ARD LLCNDACurrent
63004-8710H.P. ActharRepository CorticotropinMallinckrodt ARD Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44753ORIG2011-07-20
42524ORIG2011-07-20
43866ORIG2010-11-01
29727ORIG2010-10-20
38706ORIG2010-10-19