mycophenolate mofetil Oral Tablet

Brand(s)
Cellcept
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Genentech, Inc. (2015-07-20)
Oldest Current Product
1997-06-19
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\MYCOPHENOLATE MOFETIL
FDAOB
ORAL\TABLET\MYCOPHENOLATE MOFETIL
SPL Active
ORAL\TABLET, COATED\MYCOPHENOLATE MOFETIL
ORAL\TABLET, FILM COATED\MYCOPHENOLATE MOFETIL
ORAL\TABLET\MYCOPHENOLATE MOFETIL
SPL Moiety
ORAL\TABLET, COATED\MYCOPHENOLIC ACID
ORAL\TABLET, FILM COATED\MYCOPHENOLIC ACID
ORAL\TABLET\MYCOPHENOLIC ACID

product(s) by strength(s)

mycophenolate mofetil 500 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000040260CellceptNDAGenentech, Inc.1997-06-19MYCOPHENOLATE MOFETILORALTABLET, FILM COATEDNDA05072337241e87-4af4-4dc3-a1aa-ea6f20d8dc40

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540166ANDARoxane Laboratories, Inc2008-07-29MYCOPHENOLATE MOFETILORALTABLETANDA065413e94895d9-f040-4a75-9f04-9814238b8f3c
2000937477ANDATeva Pharmaceuticals Usa Inc2009-05-05MYCOPHENOLATE MOFETILORALTABLET, FILM COATEDANDA065457b414303f-e6f3-4e22-a537-96be352b59a4
3003784472ANDAMylan Pharmaceuticals Inc.2009-05-04MYCOPHENOLATE MOFETILORALTABLET, FILM COATEDANDA06552174c3a01e-9451-0f2f-6aab-8348047cb1f5
4007815175ANDASandoz Inc2008-10-15MYCOPHENOLATE MOFETILORALTABLETANDA065451fa37d1be-c5a5-41c6-88ea-218f551dbbb5
5167290019ANDAAccord Healthcare Inc.2009-05-04MYCOPHENOLATE MOFETILORALTABLETANDA065416741e079a-646b-47ec-84ac-8e12574c2aaf
6597460268ANDAJubilant Cadista Pharmaceuticals, Inc.2013-08-01MYCOPHENOLATE MOFETILORALTABLET, FILM COATEDANDA0906612b5d7ab6-6c3c-a206-952e-6c5c5386265e
7597620702ANDAGreenstone Llc2010-06-11MYCOPHENOLATE MOFETILORALTABLET, FILM COATEDANDA090456209efe01-7908-46e4-a964-0665078c0acd
8605052967ANDAApotex Corp2009-05-04MYCOPHENOLATE MOFETILORALTABLET, COATEDANDA09049975e05dc4-a378-4437-e399-6f890232206b
9643800725ANDAStrides Arcolab Limited2010-11-06MYCOPHENOLATE MOFETILORALTABLET, FILM COATEDANDA09045632dd890a-cfe3-4129-bce6-1d3dbe38e4f3
10678770225ANDAAscend Laboratories, Llc2011-11-28MYCOPHENOLATE MOFETILORALTABLET, FILM COATEDANDA0912499f84ea84-2d8b-4d91-a33f-7dfb5df937dc

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1499990937CellceptNDALake Erie Medical Dba Quality Care Products Llc1997-06-19MYCOPHENOLATE MOFETILORALTABLET, FILM COATED000040260NDA050723ca059bbf-0341-4e9d-8537-8b0c30ff42c7
2510790379ANDAMylan Institutional Inc.2009-06-01MYCOPHENOLATE MOFETILORALTABLET, FILM COATED003784472ANDA06552152907069-4a29-4351-a830-a9ee86b5ff7c
3551545382ANDACardinal Health2011-10-25MYCOPHENOLATE MOFETILORALTABLET510790379ANDA065521e1904c28-8c19-44da-b395-1e4bd08d6122
4604290070ANDAGolden State Medical Supply, Inc.2015-01-06MYCOPHENOLATE MOFETILORALTABLET, FILM COATED003784472ANDA0655211546c504-adfb-453c-a682-8e41888e8b4e
5680840588ANDAAmerican Health Packaging2012-07-022015-12-31MYCOPHENOLATE MOFETILORALTABLET, COATED605052967ANDA0904991c379413-1b43-4070-8c8b-ca387588bbaf
6680840801ANDAAmerican Health Packaging2014-12-15MYCOPHENOLATE MOFETILORALTABLET007815175ANDA065451085fa99c-8795-4abf-83cd-b0864f033d19

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA065413MYCOPHENOLATE MOFETILROXANE LABORATORIES INC2008-07-29ANDA065413_001
2ANDA065416MYCOPHENOLATE MOFETILACCORD HEALTHCARE INC2009-05-04ANDA065416_001
3ANDA065451MYCOPHENOLATE MOFETILSANDOZ INC2008-10-15ANDA065451_001
4ANDA065457MYCOPHENOLATE MOFETILTEVA PHARMACEUTICALS USA2009-05-04ANDA065457_001
5ANDA065477MYCOPHENOLATE MOFETILTrueZYDUS PHARMACEUTICALS USA INC2009-05-04ANDA065477_001
6ANDA065521MYCOPHENOLATE MOFETILMYLAN PHARMACEUTICALS INC2009-05-04ANDA065521_001
7ANDA090456MYCOPHENOLATE MOFETILSTRIDES PHARMA GLOBAL PTE LTD2010-06-10ANDA090456_001
8ANDA090464MYCOPHENOLATE MOFETILTrueDR REDDYS LABORATORIES LTD2010-09-13ANDA090464_001
9ANDA090499MYCOPHENOLATE MOFETILAPOTEX INC2009-04-22ANDA090499_001
10ANDA090606MYCOPHENOLATE MOFETILVINTAGE PHARMACEUTICALS LLC2010-07-16ANDA090606_001
11ANDA090661MYCOPHENOLATE MOFETILCADISTA PHARMACEUTICALS INC2014-12-15ANDA090661_001
12ANDA091249MYCOPHENOLATE MOFETILALKEM LABORATORIES LTD2011-11-04ANDA091249_001
13NDA050723CELLCEPTROCHE PALO ALTO LLC1997-06-19NDA050723_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA065413_001RXMYCOPHENOLATE MOFETIL (500MG)ORALTABLETFalseAB2008-07-29MYCOPHENOLATE MOFETIL
2ANDA065416_001RXMYCOPHENOLATE MOFETIL (500MG)ORALTABLETFalseAB2009-05-04MYCOPHENOLATE MOFETIL
3ANDA065451_001RXMYCOPHENOLATE MOFETIL (500MG)ORALTABLETFalseAB2008-10-15MYCOPHENOLATE MOFETIL
4ANDA065457_001RXMYCOPHENOLATE MOFETIL (500MG)ORALTABLETFalseAB2009-05-04MYCOPHENOLATE MOFETIL
5ANDA065477_001discontinuedMYCOPHENOLATE MOFETIL (500MG)ORALTABLETFalse2009-05-04MYCOPHENOLATE MOFETIL
6ANDA065521_001RXMYCOPHENOLATE MOFETIL (500MG)ORALTABLETFalseAB2009-05-04MYCOPHENOLATE MOFETIL
7ANDA090456_001RXMYCOPHENOLATE MOFETIL (500MG)ORALTABLETFalseAB2010-06-10MYCOPHENOLATE MOFETIL
8ANDA090464_001discontinuedMYCOPHENOLATE MOFETIL (500MG)ORALTABLETFalse2010-09-13MYCOPHENOLATE MOFETIL
9ANDA090499_001RXMYCOPHENOLATE MOFETIL (500MG)ORALTABLETFalseAB2009-04-22MYCOPHENOLATE MOFETIL
10ANDA090606_001RXMYCOPHENOLATE MOFETIL (500MG)ORALTABLETFalseAB2010-07-16MYCOPHENOLATE MOFETIL
11ANDA090661_001RXMYCOPHENOLATE MOFETIL (500MG)ORALTABLETFalseAB2014-12-15MYCOPHENOLATE MOFETIL
12ANDA091249_001RXMYCOPHENOLATE MOFETIL (500MG)ORALTABLETFalseAB2011-11-04MYCOPHENOLATE MOFETIL
13NDA050723_001RXMYCOPHENOLATE MOFETIL (500MG)ORALTABLETTrueAB1997-06-19CELLCEPT

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1085fa99c-8795-4abf-83cd-b0864f033d19 (view SPL)Mycophenolate Mofetil Tablets 8280101/0714Rx onlyprescriptionHuman PrescriptionAmerican Health PackagingREPACK2014-12-101680840801
21546c504-adfb-453c-a682-8e41888e8b4e (view SPL)MYCOPHENOLATE MOFETIL CAPSULES USP, 250 mg and MYCOPHENOLATE MOFETIL TABLETS USP, 500 mg Rx onlyprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2015-04-092604290070, 604290059mycophenolate mofetil Oral Capsule
31c379413-1b43-4070-8c8b-ca387588bbaf (view SPL)Mycophenolate Mofetil Capsules 250 mg, Mycophenolate Mofetil Tablets 500 mg Rx onlyprescriptionHuman PrescriptionAmerican Health Packagingrepack2015-10-014680840588, 680840587mycophenolate mofetil Oral Capsule
4209efe01-7908-46e4-a964-0665078c0acd (view SPL)mycophenolate mofetil tabletsmycophenolate mofetil capsulesprescriptionHuman PrescriptionGreenstone LlcManufacture2010-09-162597620702
52b5d7ab6-6c3c-a206-952e-6c5c5386265e (view SPL)Mycophenolate Mofetil Capsules, USP Mycophenolate Mofetil Tablets, USP Rx OnlyprescriptionHuman PrescriptionJubilant Cadista Pharmaceuticals, Inc.MANUFACTURE2015-08-126597460268, 597460267mycophenolate mofetil Oral Capsule
632dd890a-cfe3-4129-bce6-1d3dbe38e4f3 (view SPL)mycophenolate mofetil tablets, USPmycophenolate mofetil capsules, USPRx only06/2014prescriptionHuman PrescriptionStrides Arcolab LimitedAnalysis, Manufacture, Pack2014-06-245643800725
737241e87-4af4-4dc3-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, PACK2015-07-2026000040260, 000040259, 000040261, 000040298mycophenolate mofetil Oral Capsule
mycophenolate mofetil Oral Suspension
mycophenolate mofetil Injectable Solution
852907069-4a29-4351-a830-a9ee86b5ff7c (view SPL)MYCOPHENOLATE MOFETIL CAPSULES USP, 250 mg and MYCOPHENOLATE MOFETIL TABLETS USP, 500 mg Rx onlyprescriptionHuman PrescriptionMylan Institutional Inc.2014-05-023510790379, 510790721mycophenolate mofetil Oral Capsule
9741e079a-646b-47ec-84ac-8e12574c2aaf (view SPL)Mycophenolate Mofetil Capsules USP 250 mg Mycophenolate Mofetil Tablets USP 500 mg Rx onlyprescriptionHuman PrescriptionAccord Healthcare Inc.analysis, manufacture2015-11-166167290019, 167290094mycophenolate mofetil Oral Capsule
1074c3a01e-9451-0f2f-6aab-8348047cb1f5 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-09-308003784472, 003782250mycophenolate mofetil Oral Capsule
1175e05dc4-a378-4437-e399-6f890232206b (view SPL)Mycophenolate Mofetil Capsules, USP 250 mg Mycophenolate Mofetil Tablets, USP 500 mg Rx onlyprescriptionHuman PrescriptionApotex Corp2015-08-035605052967, 605052968mycophenolate mofetil Oral Capsule
129f84ea84-2d8b-4d91-a33f-7dfb5df937dc (view SPL)Mycophenolate Mofetil Tablets USP 500 mg Mycophenolate Mofetil Capsules USP 250 mgprescriptionHuman PrescriptionAscend Laboratories, LlcMANUFACTURE2013-09-2411678770225, 678770266mycophenolate mofetil Oral Capsule
13b414303f-e6f3-4e22-a537-96be352b59a4 (view SPL)MYCOPHENOLATE MOFETIL CAPSULES USP, 250 mg and MYCOPHENOLATE MOFETIL TABLETS USP, 500 mg Rx only 73347477prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-08-1715000937477, 000937334mycophenolate mofetil Oral Capsule
14ca059bbf-0341-4e9d-8537-8b0c30ff42c7 (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 PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2012-05-223807499990937
15e1904c28-8c19-44da-b395-1e4bd08d6122 (view SPL)MYCOPHENOLATE MOFETIL CAPSULES USP, 250 mg and MYCOPHENOLATE MOFETIL TABLETS USP, 500 mg Rx onlyprescriptionHuman PrescriptionCardinal HealthREPACK2014-12-086551545382, 551546262mycophenolate mofetil Oral Capsule
16e94895d9-f040-4a75-9f04-9814238b8f3c (view SPL)prescriptionHuman PrescriptionRoxane Laboratories, IncMANUFACTURE2014-05-0310000540166, 000540163mycophenolate mofetil Oral Capsule
17fa37d1be-c5a5-41c6-88ea-218f551dbbb5 (view SPL)Mycophenolate Mofetil Tablets Rx onlyprescriptionHuman PrescriptionSandoz Inc2015-08-257007815175

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