aminosalicylic acid Oral Granules

Brand(s)
Paser D/R
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Jacobus Pharmaceutical Company, Inc. (2010-06-01)
Oldest Current Product
1995-02-15
License(s)
ANDA
RxNORM
ORAL GRANULES\AMINOSALICYLIC ACID
FDAOB
ORAL\GRANULE, DELAYED RELEASE\AMINOSALICYLIC ACID
SPL Active
ORAL\GRANULE, DELAYED RELEASE\AMINOSALICYLIC ACID
SPL Moiety
ORAL\GRANULE, DELAYED RELEASE\AMINOSALICYLIC ACID

product(s) by strength(s)

aminosalicylic acid 4000 mg oral granules

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1499380107Paser D/RANDAJacobus Pharmaceutical Company, Inc.1995-02-15AMINOSALICYLIC ACIDORALGRANULE, DELAYED RELEASEANDA0743466f2753dc-5f0c-4f49-9335-e519afb69ba6

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA074346PASERJACOBUS PHARMACEUTICAL CO1994-06-30ANDA074346_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA074346_001RXAMINOSALICYLIC ACID (4GM/PACKET)ORALGRANULE, DELAYED RELEASETrue1994-06-30PASER

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
16f2753dc-5f0c-4f49-9335-e519afb69ba6 (view SPL)PASER GRANULES(Aminosalicylic Acid Delayed-Release Granules)prescriptionHuman PrescriptionJacobus Pharmaceutical Company, Inc.2010-06-011499380107

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