Indomethacin Oral Suspension

Brand(s)
Indocin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Iroko Pharmaceuticals, Llc (2012-11-21)
Oldest Current Product
1985-10-10
License(s)
NDA
RxNORM
ORAL SUSPENSION\INDOMETHACIN
FDAOB
ORAL\SUSPENSION\INDOMETHACIN
SPL Active
ORAL\SUSPENSION\INDOMETHACIN
SPL Moiety
ORAL\SUSPENSION\INDOMETHACIN

product(s) by strength(s)

indomethacin 5 mg/ml oral suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1422110101IndocinNDAIroko Pharmaceuticals, Llc1985-10-10INDOMETHACINORALSUSPENSIONNDA01833206de3c9d-63bf-47c1-f78c-4fbdd482928a

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA071412INDOMETHACINTrueCYCLE PHARMACEUTICALS LTD1987-03-18ANDA071412_001
2NDA018332INDOCINIROKO PHARMACEUTICALS LLC1985-10-10NDA018332_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA071412_001discontinuedINDOMETHACIN (25MG/5ML)ORALSUSPENSIONFalse1987-03-18INDOMETHACIN
2NDA018332_001RXINDOMETHACIN (25MG/5ML)ORALSUSPENSIONTrue1985-10-10INDOCIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
106de3c9d-63bf-47c1-f78c-4fbdd482928a (view SPL)INDOCIN (INDOMETHACIN) ORAL SUSPENSIONprescriptionHuman PrescriptionIroko Pharmaceuticals, Llcmanufacture2012-11-219422110101

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