Corticotropin Injectable Solution

Brand(s)
Acthar
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mallinckrodt Ard Inc. (2015-01-21)
Oldest Current Product
2013-01-07
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\CORTICOTROPIN
FDAOB
INJECTION\INJECTION\CORTICOTROPIN\rdfq
SPL Active
INTRAMUSCULAR\INJECTION\CORTICOTROPIN
SPL Moiety
INTRAMUSCULAR\INJECTION\CORTICOTROPIN

product(s) by strength(s)

corticotropin 80 unt/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1630048710ActharNDAMallinckrodt Ard Inc.2013-01-07CORTICOTROPININTRAMUSCULARINJECTIONNDA0083727b48ddec-e815-45f4-9ca0-5c0daaf56f30

application(s)

#idtitledeprecatedapplicantapprovedexclusivityapproved drug
1ANDA088772CORTICOTROPINTrueWATSON LABORATORIES INC1984-11-21ANDA088772_001
2NDA007504ACTHARTrueSANOFI AVENTIS US LLCNDA007504_002, NDA007504_003
3NDA008317ACTHTruePARKEDALE PHARMACEUTICALS INCNDA008317_002, NDA008317_004
4NDA008372H.P. ACTHAR GELMALLINCKRODT ARD INCORPHAN DRUG EXCLUSIVITY [2017-10-15]NDA008372_006, NDA008372_008
5NDA008975PURIFIED CORTROPHIN GELTrueORGANON USA INCNDA008975_001, NDA008975_002
6NDA010831CORTICOTROPINTrueORGANICS LAGRANGE INCNDA010831_001, NDA010831_002

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1ANDA088772_001discontinuedCORTICOTROPIN (40 UNITS/VIAL)INJECTIONFalse1984-11-21CORTICOTROPIN
2NDA007504_002discontinuedCORTICOTROPIN (25 UNITS/VIAL)INJECTIONFalseACTHAR
3NDA007504_003discontinuedCORTICOTROPIN (40 UNITS/VIAL)INJECTIONFalseACTHAR
4NDA008317_002discontinuedCORTICOTROPIN (25 UNITS/VIAL)INJECTIONFalseACTH
5NDA008317_004discontinuedCORTICOTROPIN (40 UNITS/VIAL)INJECTIONFalseACTH
6NDA008372_006discontinuedCORTICOTROPIN (40 UNITS/ML)INJECTIONFalseH.P. ACTHAR GEL
7NDA008372_008RXCORTICOTROPIN (80 UNITS/ML)INJECTIONTrueH.P. ACTHAR GEL
8NDA008975_001discontinuedCORTICOTROPIN (40 UNITS/ML)INJECTIONFalsePURIFIED CORTROPHIN GEL
9NDA008975_002discontinuedCORTICOTROPIN (80 UNITS/ML)INJECTIONFalsePURIFIED CORTROPHIN GEL
10NDA010831_001discontinuedCORTICOTROPIN (40 UNITS/ML)INJECTIONFalseCORTICOTROPIN
11NDA010831_002discontinuedCORTICOTROPIN (80 UNITS/ML)INJECTIONFalseCORTICOTROPIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
17b48ddec-e815-45f4-9ca0-5c0daaf56f30 (view SPL)These highlights do not include all the information needed to use H.P. Acthar Gel safely and effectively. See full prescribing information for H.P. Acthar Gel. H.P. Acthar Gel (repository corticotropin injection) INJECTION, GEL for INTRAMUSCULAR | SUBCUTANEOUS use Initial U.S. Approval: 1952prescriptionHuman PrescriptionMallinckrodt Ard Inc.MANUFACTURE2015-01-213630048710

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII