olsalazine Oral Capsule

Brand(s)
Dipentum
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Meda Pharmaceuticals Inc. (2015-05-15)
Oldest Current Product
1990-07-31
License(s)
NDA
RxNORM
ORAL CAPSULE\OLSALAZINE
FDAOB
ORAL\CAPSULE\OLSALAZINE SODIUM
SPL Active
ORAL\CAPSULE, GELATIN COATED\OLSALAZINE SODIUM
SPL Moiety
ORAL\CAPSULE, GELATIN COATED\OLSALAZINE

product(s) by strength(s)

olsalazine sodium 250 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000376860DipentumNDAMeda Pharmaceuticals Inc.2015-05-15OLSALAZINE SODIUMORALCAPSULE, GELATIN COATEDNDA0197158512d0c6-db4e-4673-b3b4-28975c18413f

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1681513120DipentumNDACarilion Materials Management1990-07-31OLSALAZINE SODIUMORALCAPSULE, GELATIN COATED682200160NDA019715373c321f-cd33-4c11-a2d6-73f38384c27f

application(s)

#idtitleapplicantapprovedapproved drug
1NDA019715DIPENTUMMEDA PHARMACEUTICALS INC1990-07-31NDA019715_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA019715_001RXOLSALAZINE SODIUM (250MG)ORALCAPSULETrue1990-07-31DIPENTUM

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1373c321f-cd33-4c11-a2d6-73f38384c27f (view SPL)Dipentum (olsalazine sodium capsules) prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2009-10-052681513120
28512d0c6-db4e-4673-b3b4-28975c18413f (view SPL)PrDipentum (olsalazine sodium)capsule, gelatin coated Rx OnlyCIP70006APT#CIA60342Rev. 1/2014 CIP70006AprescriptionHuman PrescriptionMeda Pharmaceuticals Inc.2015-05-151000376860
3f4858879-0b8b-484a-9742-112c92662e8a (view SPL)Dipentum (olsalazine sodium capsules)prescriptionHuman PrescriptionAlaven Pharmaceutical2009-10-051682200160

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