Home Applications 050759 Application 050759
Type NDA
Sponsor ROCHE PALO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CELLCEPT MYCOPHENOLATE MOFETIL SUSPENSION;ORAL 200MG/ML Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050759-001 CELLCEPT MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB RLD, RS 1998-10-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N050759-001 AB
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 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N050759-001 CELLCEPT 200MG/ML FOR SUSPENSION / ORAL AB RLD, RS 1998-10-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N050759-001 CELLCEPT 200MG/ML FOR SUSPENSION / ORAL AB RLD, RS 1998-10-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050759-001 CELLCEPT 200MG/ML FOR SUSPENSION / ORAL AB RLD, RS 1998-10-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050759-001 CELLCEPT 200MG/ML FOR SUSPENSION / ORAL AB RLD, RS 1998-10-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050759-001 CELLCEPT 200MG/ML FOR SUSPENSION / ORAL AB RLD, RS 1998-10-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050759-001 CELLCEPT 200MG/ML FOR SUSPENSION / ORAL AB RLD, RS 1998-10-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050759-001 CELLCEPT 200MG/ML FOR SUSPENSION / ORAL AB RLD, RS 1998-10-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050759-001 CELLCEPT 200MG/ML FOR SUSPENSION / ORAL AB RLD, RS 1998-10-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050759-001 CELLCEPT 200MG/ML FOR SUSPENSION / ORAL AB RLD, RS 1998-10-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050759-001 CELLCEPT 200MG/ML FOR SUSPENSION / ORAL AB RLD, RS 1998-10-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050759-001 CELLCEPT 200MG/ML FOR SUSPENSION / ORAL AB RLD, RS 1998-10-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050759-001 CELLCEPT 200MG/ML FOR SUSPENSION / ORAL AB RLD, RS 1998-10-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050759-001 CELLCEPT 200MG/ML FOR SUSPENSION / ORAL AB RLD, RS 1998-10-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050759-001 CELLCEPT 200MG/ML FOR SUSPENSION / ORAL AB RLD, RS 1998-10-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050759-001 CELLCEPT 200MG/ML FOR SUSPENSION / ORAL AB RLD, RS 1998-10-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050759-001 CELLCEPT 200MG/ML FOR SUSPENSION / ORAL AB RLD, RS 1998-10-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050759-001 CELLCEPT 200MG/ML FOR SUSPENSION / ORAL AB RLD, RS 1998-10-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050759-001 CELLCEPT 200MG/ML FOR SUSPENSION / ORAL AB RLD, RS 1998-10-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050759-001 CELLCEPT 200MG/ML SUSPENSION / ORAL AB RLD, RS 1998-10-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050759-001 CELLCEPT 200MG/ML FOR SUSPENSION / ORAL AB RLD, RS 1998-10-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050759-001 CELLCEPT 200MG/ML FOR SUSPENSION / ORAL AB RLD, RS 1998-10-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050759-001 CELLCEPT 200MG/ML SUSPENSION / ORAL AB RLD, RS 1998-10-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050759-001 CELLCEPT 200MG/ML SUSPENSION / ORAL AB RLD, RS 1998-10-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050759-001 CELLCEPT 200MG/ML SUSPENSION / ORAL AB RLD, RS 1998-10-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050759-001 CELLCEPT 200MG/ML SUSPENSION / ORAL AB RLD, RS 1998-10-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050759-001 CELLCEPT 200MG/ML SUSPENSION / ORAL AB RLD, RS 1998-10-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050759-001 CELLCEPT 200MG/ML SUSPENSION / ORAL AB RLD, RS 1998-10-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050759-001 CELLCEPT 200MG/ML SUSPENSION / ORAL AB RLD, RS 1998-10-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050759-001 CELLCEPT 200MG/ML FOR SUSPENSION / ORAL AB RLD, RS 1998-10-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N050759-001 CELLCEPT 200MG/ML FOR SUSPENSION / ORAL AB RLD, RS 1998-10-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N050759-001 CELLCEPT 200MG/ML FOR SUSPENSION / ORAL AB RLD, RS 1998-10-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050759-001 CELLCEPT 200MG/ML FOR SUSPENSION / ORAL AB RLD, RS 1998-10-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050759-001 CELLCEPT 200MG/ML FOR SUSPENSION / ORAL AB RLD, RS 1998-10-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050759-001 CELLCEPT 200MG/ML FOR SUSPENSION / ORAL AB RLD, RS 1998-10-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050759-001 CELLCEPT 200MG/ML FOR SUSPENSION / ORAL AB RLD, RS 1998-10-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N050759-001 CELLCEPT 200MG/ML FOR SUSPENSION / ORAL AB RLD, RS 1998-10-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N050759-001 CELLCEPT 200MG/ML FOR SUSPENSION / ORAL AB RLD, RS 1998-10-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050759-001 CELLCEPT 200MG/ML FOR SUSPENSION / ORAL AB RLD, RS 1998-10-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N050759-001 CELLCEPT 200MG/ML FOR SUSPENSION / ORAL AB RLD, RS 1998-10-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N050759-001 CELLCEPT 200MG/ML FOR SUSPENSION / ORAL AB RLD, RS 1998-10-01 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CellCept MYCOPHENOLATE MOFETIL Genentech, Inc. 37241e87-4af4-4dc3-a1aa-ea6f20d8dc40 2026-08-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 050759 application number: NDA050759 ndc (product): 0004-0261
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0004-0261 CellCept Mycophenolate Mofetil Genentech, Inc. NDA Current 0004-0261 CellCept Mycophenolate Mofetil Genentech, Inc. NDA Current 0004-0261 CellCept Mycophenolate Mofetil Genentech, Inc. NDA Current 0004-0261 CellCept Mycophenolate Mofetil Genentech, Inc. NDA Current 0004-0261 CellCept Mycophenolate Mofetil Genentech, Inc. NDA Current 0004-0261 CellCept Mycophenolate Mofetil Genentech, Inc. NDA Current 0004-0261 CellCept Mycophenolate Mofetil Genentech, Inc. NDA Current 0004-0261 CellCept Mycophenolate Mofetil Genentech, Inc. NDA Current 0004-0261 CellCept Mycophenolate Mofetil Genentech, Inc. NDA Current