Indomethacin Rectal Suppository

Brand(s)
Indocin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
G&W Laboratories, Inc. (2011-07-12)
Oldest Current Product
1992-08-31
License(s)
ANDA
RxNORM
RECTAL SUPPOSITORY\INDOMETHACIN
FDAOB
RECTAL\SUPPOSITORY\INDOMETHACIN
SPL Active
RECTAL\SUPPOSITORY\INDOMETHACIN
SPL Moiety
RECTAL\SUPPOSITORY\INDOMETHACIN

product(s) by strength(s)

indomethacin 50 mg rectal suppository

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007130176ANDAG&W Laboratories, Inc.1992-08-31INDOMETHACINRECTALSUPPOSITORYANDA073314a8ed14ef-cd4b-3be7-0b5f-b677c72d2e88
2422110102IndocinANDAIroko Pharmaceuticals, Llc1992-08-31INDOMETHACINRECTALSUPPOSITORYANDA073314e30a54dc-b62a-4ef7-9bea-daa8f5a685be

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA073314INDOMETHACING AND W LABORATORIES INC1992-08-31ANDA073314_001
2NDA017814INDOCINTrueIROKO PHARMACEUTICALS LLC1984-08-13NDA017814_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA073314_001RXINDOMETHACIN (50MG)RECTALSUPPOSITORYTrue1992-08-31INDOMETHACIN
2NDA017814_001discontinuedINDOMETHACIN (50MG)RECTALSUPPOSITORYFalse1984-08-13INDOCIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1a8ed14ef-cd4b-3be7-0b5f-b677c72d2e88 (view SPL)prescriptionHuman PrescriptionG&W Laboratories, Inc.MANUFACTURE2011-07-121007130176
2e30a54dc-b62a-4ef7-9bea-daa8f5a685be (view SPL)prescriptionHuman PrescriptionIroko Pharmaceuticals, LlcMANUFACTURE2011-07-122422110102

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