Home Applications 065451 Application 065451
Type ANDA
Sponsor SANDOZ Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL TABLET;ORAL 500MG No No
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 A065451-001 MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065451-001 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 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0480-3571 Mycophenolate Mofetil Mycophenolate Mofetil Teva Pharmaceuticals USA, Inc. ANDA Current 0781-5175 Mycophenolate Mofetil Mycophenolate Mofetil Sandoz Inc ANDA Current 0781-5175 Mycophenolate Mofetil Mycophenolate Mofetil Sandoz Inc ANDA Current 0781-5175 Mycophenolate Mofetil Mycophenolate Mofetil Sandoz Inc ANDA Current 0781-5175 Mycophenolate Mofetil Mycophenolate Mofetil Sandoz Inc ANDA Current 0781-5175 Mycophenolate Mofetil Mycophenolate Mofetil Sandoz Inc ANDA Current 68084-801 Mycophenolate mofetil Mycophenolate mofetil American Health Packaging ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 24043 ORIG 2015-07-06 23748 ORIG 2009-07-15