Indomethacin Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
App Pharmaceuticals, Llc (2014-04-29)
Oldest Current Product
2010-03-19
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\INDOMETHACIN
FDAOB
INJECTION\INJECTION\INDOMETHACIN\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\INDOMETHACIN
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\INDOMETHACIN

product(s) by strength(s)

indomethacin 1 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1633230659NDAApp Pharmaceuticals, Llc2010-03-19INDOMETHACININTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA02253630e38747-c553-4e2d-bc23-634e1dd90b8d, dd5caa3f-3c09-4034-bf43-2df80c61c07b, ec482425-358c-4500-8f5d-79c1379c1fa8

application(s)

#idtitleapplicantapprovedapproved drug
1NDA022536INDOMETHACINFRESENIUS KABI USA LLC2010-03-17NDA022536_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA022536_001RXINDOMETHACIN (EQ 1MG BASE/VIAL)INJECTIONTrue2010-03-17INDOMETHACIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
130e38747-c553-4e2d-bc23-634e1dd90b8d (view SPL)These highlights do not include all the information needed to use Indomethacin for Injection safely and effectively. See full prescribing information for Indomethacin for Injection. Indomethacin for InjectionInitial U.S. Approval: 1965prescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-04-292633230659
2dd5caa3f-3c09-4034-bf43-2df80c61c07b (view SPL)These highlights do not include all the information needed to use Indomethacin for Injection safely and effectively. See full prescribing information for Indomethacin for Injection. Indomethacin for Injection Initial U.S. Approval: 1965prescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2013-07-312633230659
3ec482425-358c-4500-8f5d-79c1379c1fa8 (view SPL)These highlights do not include all the information needed to use Indomethacin for Injection safely and effectively. See full prescribing information for Indomethacin for Injection. Indomethacin for InjectionInitial U.S. Approval: 1965prescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-04-294633230659

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