mycophenolate mofetil Injectable Solution

Brand(s)
Cellcept
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Genentech, Inc. (2015-07-20)
Oldest Current Product
1998-08-12
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\MYCOPHENOLATE MOFETIL
FDAOB
INJECTION\INJECTION\MYCOPHENOLATE MOFETIL HYDROCHLORIDE\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\MYCOPHENOLATE MOFETIL HYDROCHLORIDE
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\MYCOPHENOLIC ACID

product(s) by strength(s)

mycophenolate mofetil 6 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000040298CellceptNDAGenentech, Inc.1998-08-12MYCOPHENOLATE MOFETIL HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA05075837241e87-4af4-4dc3-a1aa-ea6f20d8dc40

application(s)

#idtitleapplicantapprovedapproved drug
1NDA050758CELLCEPTROCHE PALO ALTO LLC1998-08-12NDA050758_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA050758_001RXMYCOPHENOLATE MOFETIL HYDROCHLORIDE (500MG/VIAL)INJECTIONTrue1998-08-12CELLCEPT

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
137241e87-4af4-4dc3-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, PACK2015-07-2026000040298, 000040259, 000040260, 000040261mycophenolate mofetil Oral Capsule
mycophenolate mofetil Oral Suspension
mycophenolate mofetil Oral Tablet

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