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

NDC Listings For This Application#

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