Home Applications 075568 Application 075568
Type ANDA
Sponsor MYLAN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AZATHIOPRINE AZATHIOPRINE TABLET;ORAL 50MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A075568-001 AZATHIOPRINE AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075568-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075568-001 AZATHIOPRINE 50MG TABLET / ORAL AB 1999-12-13 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 AZATHIOPRINE AZATHIOPRINE Rising Pharma Holdings, Inc. 2ffa2fce-895d-469e-8667-b078560aec5f 2025-02-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075568 application number: ANDA075568
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0378-1005 Azathioprine azathioprine Mylan Pharmaceuticals Inc. ANDA Current 0378-1005 Azathioprine azathioprine Mylan Pharmaceuticals Inc. ANDA Current 43353-745 Azathioprine azathioprine Aphena Pharma Solutions - Tennessee, LLC ANDA Current 51079-620 Azathioprine azathioprine Mylan Institutional Inc. ANDA Current 51079-620 Azathioprine azathioprine Mylan Institutional Inc. ANDA Current 51079-620 Azathioprine azathioprine Mylan Institutional Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 30939 ORIG 1999-12-13