mycophenolate mofetil Oral Suspension

Brand(s)
Cellcept
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Genentech, Inc. (2015-07-20)
Oldest Current Product
1998-10-01
License(s)
NDA, ANDA
RxNORM
ORAL SUSPENSION\MYCOPHENOLATE MOFETIL
FDAOB
ORAL\SUSPENSION\MYCOPHENOLATE MOFETIL
SPL Active
ORAL\POWDER, FOR SUSPENSION\MYCOPHENOLATE MOFETIL
SPL Moiety
ORAL\POWDER, FOR SUSPENSION\MYCOPHENOLIC ACID

product(s) by strength(s)

mycophenolate mofetil 200 mg/ml oral suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000040261CellceptNDAGenentech, Inc.1998-10-01MYCOPHENOLATE MOFETILORALPOWDER, FOR SUSPENSIONNDA05075937241e87-4af4-4dc3-a1aa-ea6f20d8dc40

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1678770230ANDAAscend Laboratories, Llc2014-11-17MYCOPHENOLATE MOFETILORALPOWDER, FOR SUSPENSIONANDA20300521ff53b0-b4ba-4473-91e4-76ef41681064

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA203005MYCOPHENOLATE MOFETILALKEM LABORATORIES LTD2014-11-14ANDA203005_001
2NDA050759CELLCEPTROCHE PALO ALTO LLC1998-10-01p5688529, SUBSTANCENDA050759_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA203005_001RXMYCOPHENOLATE MOFETIL (200MG/ML)ORALSUSPENSIONFalseAB2014-11-14MYCOPHENOLATE MOFETIL
2NDA050759_001RXMYCOPHENOLATE MOFETIL (200MG/ML)ORALSUSPENSIONTrueAB1998-10-01CELLCEPT

patent(s)

#idexpiration dateapplication(s)
1p5688529 (view patent)2014-11-18NDA050759

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
121ff53b0-b4ba-4473-91e4-76ef41681064 (view SPL)Mycophenolate Mofetil for Oral Suspension USPprescriptionHuman PrescriptionAscend Laboratories, LlcMANUFACTURE2015-10-2010678770230
237241e87-4af4-4dc3-a1aa-ea6f20d8dc40 (view SPL)CellCept (mycophenolate mofetil capsules) (mycophenolate mofetil tablets) CellCept Oral Suspension (mycophenolate mofetil for oral suspension) CellCept Intravenous (mycophenolate mofetil hydrochloride for injection)prescriptionHuman PrescriptionGenentech, Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-07-2026000040261, 000040259, 000040260, 000040298mycophenolate mofetil Oral Capsule
mycophenolate mofetil Injectable Solution
mycophenolate mofetil Oral Tablet

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