Cosyntropin Injectable Solution

Brand(s)
Cortrosyn
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Amphastar Pharmaceuticals, Inc. (2015-05-19)
Oldest Current Product
2003-08-01
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\COSYNTROPIN
FDAOB
INJECTION\INJECTION\COSYNTROPIN\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\COSYNTROPIN
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\COSYNTROPIN
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\COSYNTROPIN
SPL Moiety
INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\COSYNTROPIN
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\COSYNTROPIN
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\COSYNTROPIN

product(s) by strength(s)

cosyntropin 0.25 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005485900CortrosynNDAAmphastar Pharmaceuticals, Inc.2003-08-01COSYNTROPININTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA016750746856e9-3930-4f6a-b8e6-a03845d6dd0b

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007813440ANDASandoz Inc2012-06-29COSYNTROPININTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA2021471342169c-e214-4f22-8363-1fd45b85d1e8
2674570227ANDAMylan Institutional Llc2013-05-08COSYNTROPININTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA09057439af194b-c854-4abf-893a-a47856fe42a1
3674570257ANDAMylan Institutional Llc2013-05-08COSYNTROPININTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA09057439af194b-c854-4abf-893a-a47856fe42a1

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840050NDAGeneral Injecatables & Vaccines, Inc2010-03-01COSYNTROPININTRAMUSCULARINJECTION, POWDER, FOR SOLUTION005485900NDA01675090306296-77ef-4123-9f86-8a662523cc58

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA090574COSYNTROPINMYLAN INSTITUTIONAL LLC2009-12-17ANDA090574_001
2ANDA202147COSYNTROPINSANDOZ INC2012-06-29ANDA202147_001
3NDA016750CORTROSYNAMPHASTAR PHARMACEUTICALS INCNDA016750_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA090574_001RXCOSYNTROPIN (0.25MG/VIAL)INJECTIONFalseAP2009-12-17COSYNTROPIN
2ANDA202147_001RXCOSYNTROPIN (0.25MG/VIAL)INJECTIONFalseAP2012-06-29COSYNTROPIN
3NDA016750_001RXCOSYNTROPIN (0.25MG/VIAL)INJECTIONTrueAPCORTROSYN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11342169c-e214-4f22-8363-1fd45b85d1e8 (view SPL)cosyntropin for injection For diagnostic use onlyprescriptionHuman PrescriptionSandoz Inc2012-07-171007813440
239af194b-c854-4abf-893a-a47856fe42a1 (view SPL)prescriptionHuman PrescriptionMylan Institutional Llc2013-01-315674570227, 674570257
3746856e9-3930-4f6a-b8e6-a03845d6dd0b (view SPL)prescriptionHuman PrescriptionAmphastar Pharmaceuticals, Inc.analysis, label, manufacture2015-05-194005485900
490306296-77ef-4123-9f86-8a662523cc58 (view SPL)Cortrosyn (cosyntropin) 0.25 mg Injection, USP 1ml VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2012-03-143525840050

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