FDA.reportPublic FDA data

Application 050759

Type
NDA
Sponsor
ROCHE PALO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CELLCEPTMYCOPHENOLATE MOFETILSUSPENSION;ORAL200MG/MLYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050759-001CELLCEPTMYCOPHENOLATE MOFETIL200MG/MLFOR SUSPENSION / ORALABRLD, RS1998-10-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N050759-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N050759-001CELLCEPT200MG/MLFOR SUSPENSION / ORALABRLD, RS1998-10-01f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N050759-001CELLCEPT200MG/MLFOR SUSPENSION / ORALABRLD, RS1998-10-01e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N050759-001CELLCEPT200MG/MLFOR SUSPENSION / ORALABRLD, RS1998-10-01cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N050759-001CELLCEPT200MG/MLFOR SUSPENSION / ORALABRLD, RS1998-10-01a50c72e98297…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09N050759-001AB1c2088c7a36db…
2026-09-14 22:38:342026-08N050759-001AB184e616aacf4f…
2026-08-18 06:07:402026-07N050759-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N050759-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050759-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N050759-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050759-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050759-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050759-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050759-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050759-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050759-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050759-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050759-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050759-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050759-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050759-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050759-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050759-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050759-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050759-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050759-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050759-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050759-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N050759-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N050759-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N050759-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N050759-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N050759-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N050759-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N050759-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N050759-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N050759-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N050759-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N050759-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N050759-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N050759-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N050759-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N050759-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N050759-001AB13a93d1ddd44b…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CellCeptMYCOPHENOLATE MOFETILGenentech, Inc.37241e87-4af4-4dc3-a1aa-ea6f20d8dc402026-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 050759
application number: NDA050759
ndc (product): 0004-0261

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0004-0261CellCeptMycophenolate MofetilGenentech, Inc.NDACurrent
0004-0261CellCeptMycophenolate MofetilGenentech, Inc.NDACurrent
0004-0261CellCeptMycophenolate MofetilGenentech, Inc.NDACurrent
0004-0261CellCeptMycophenolate MofetilGenentech, Inc.NDACurrent
0004-0261CellCeptMycophenolate MofetilGenentech, Inc.NDACurrent
0004-0261CellCeptMycophenolate MofetilGenentech, Inc.NDACurrent
0004-0261CellCeptMycophenolate MofetilGenentech, Inc.NDACurrent
0004-0261CellCeptMycophenolate MofetilGenentech, Inc.NDACurrent
0004-0261CellCeptMycophenolate MofetilGenentech, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82733SUPPL 2025-07-03
82708SUPPL 2025-06-30
79397SUPPL 2024-08-14
71788SUPPL2022-08-11
71787SUPPL2022-08-11
71773SUPPL2022-08-11
71246SUPPL2022-06-07
71245SUPPL2022-06-07
71244SUPPL2022-06-07
71230SUPPL2022-06-07
71229SUPPL2022-06-07
69103SUPPL2021-10-25
69102SUPPL2021-10-25
69095SUPPL2021-10-25
69094SUPPL2021-10-25
68361SUPPL2021-08-12
68360SUPPL2021-08-12
67158SUPPL2021-04-23
65939SUPPL2021-01-19
61305SUPPL2019-12-17
61293SUPPL2019-12-16
61292SUPPL2019-12-16
57851SUPPL2019-02-28
57842SUPPL2019-02-28
55308SUPPL2018-08-24
55289SUPPL2018-08-24
55288SUPPL2018-08-24
50874SUPPL2017-12-27
50765SUPPL2017-12-19
30491SUPPL2015-11-19
8228SUPPL2015-07-14
39293SUPPL2015-07-13
30490SUPPL2013-10-01
8227SUPPL2013-10-01
24039ORIG2012-09-27
8225SUPPL2012-09-27
30489SUPPL2012-06-26
18201SUPPL2012-06-26
18200SUPPL2012-06-18
8226SUPPL2012-06-12
30488SUPPL2009-11-09
39292SUPPL2009-10-14
44206ORIG2009-07-15
39291SUPPL2009-06-24
8224SUPPL2009-06-23
18199SUPPL2009-03-19
8223SUPPL2009-03-05
39290SUPPL2009-01-02
30487SUPPL2008-12-24
39289SUPPL2008-05-16
8222SUPPL2008-05-15
30485SUPPL2008-01-09
18198SUPPL2007-12-27
39288SUPPL2007-09-26
30486SUPPL2007-09-25
39287SUPPL2005-10-19
30484SUPPL2005-10-19
42721ORIG2005-07-11
22229SUPPL2004-10-08
8221SUPPL2003-03-10
39286SUPPL2003-02-28
42722SUPPL2000-12-22
30483SUPPL2000-12-22
18196SUPPL2000-12-22
42723SUPPL2000-07-28
18197SUPPL2000-07-28
8220SUPPL2000-07-28
8219ORIG1998-10-01