Home Applications 065521 Application 065521
Type ANDA
Sponsor MYLAN 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 A065521-001 MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL 2009-05-04
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 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL 2009-05-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 e64feba35796…
Observed Orange Book normalized TE history# 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 · 23 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0378-4472 Mycophenolate Mofetil mycophenolate mofetil Mylan Pharmaceuticals Inc ANDA Current 0378-4472 Mycophenolate Mofetil mycophenolate mofetil Mylan Pharmaceuticals Inc. ANDA Current 0378-4472 Mycophenolate Mofetil mycophenolate mofetil Mylan Pharmaceuticals Inc. ANDA Current 0378-4472 Mycophenolate Mofetil mycophenolate mofetil Mylan Pharmaceuticals Inc. ANDA Current 0378-4472 Mycophenolate Mofetil mycophenolate mofetil Mylan Pharmaceuticals Inc. ANDA Current 0378-4472 Mycophenolate Mofetil mycophenolate mofetil Mylan Pharmaceuticals Inc. ANDA Current 0378-4472 Mycophenolate Mofetil mycophenolate mofetil Mylan Pharmaceuticals Inc. ANDA Current 51079-379 Mycophenolate Mofetil mycophenolate mofetil Mylan Institutional Inc. ANDA Current 51079-379 Mycophenolate Mofetil mycophenolate mofetil Mylan Institutional Inc. ANDA Current 51079-379 Mycophenolate Mofetil mycophenolate mofetil Mylan Institutional Inc. ANDA Current 51079-379 Mycophenolate Mofetil mycophenolate mofetil Mylan Institutional Inc. ANDA Current 55154-5382 Mycophenolate Mofetil mycophenolate mofetil Cardinal Health ANDA Current 55154-5382 Mycophenolate Mofetil mycophenolate mofetil Cardinal Health ANDA Current 55154-5382 Mycophenolate Mofetil mycophenolate mofetil Cardinal Health ANDA Current 55154-5382 Mycophenolate Mofetil mycophenolate mofetil Cardinal Health 107, LLC ANDA Current 55154-5382 Mycophenolate Mofetil mycophenolate mofetil Cardinal Health ANDA Current 60429-070 Mycophenolate Mofetil mycophenolate mofetil Golden State Medical Supply, Inc. ANDA Current 60429-070 Mycophenolate Mofetil mycophenolate mofetil Golden State Medical Supply, Inc. ANDA Current 60429-070 Mycophenolate Mofetil mycophenolate mofetil Golden State Medical Supply ANDA Current 60429-070 Mycophenolate Mofetil mycophenolate mofetil Golden State Medical Supply ANDA Current 60429-070 Mycophenolate Mofetil mycophenolate mofetil Golden State Medical Supply, Inc. ANDA Current 60429-070 Mycophenolate Mofetil mycophenolate mofetil Golden State Medical Supply, Inc. ANDA Current 71610-033 Mycophenolate Mofetil mycophenolate mofetil Aphena Pharma Solutions - Tennessee, LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 44524 ORIG 2015-07-06 44246 ORIG 2009-07-15