Home Applications 211436 Application 211436
Type ANDA
Sponsor TEVA PHARMS USA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MIFEPRISTONE MIFEPRISTONE TABLET;ORAL 300MG 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 A211436-001 MIFEPRISTONE MIFEPRISTONE 300MG TABLET / ORAL AB 2020-08-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211436-001 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.
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 A211436-001 MIFEPRISTONE 300MG TABLET / ORAL AB 2020-08-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211436-001 MIFEPRISTONE 300MG TABLET / ORAL AB 2020-08-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211436-001 MIFEPRISTONE 300MG TABLET / ORAL AB 2020-08-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211436-001 MIFEPRISTONE 300MG TABLET / ORAL AB 2020-08-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211436-001 MIFEPRISTONE 300MG TABLET / ORAL AB 2020-08-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211436-001 MIFEPRISTONE 300MG TABLET / ORAL AB 2020-08-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211436-001 MIFEPRISTONE 300MG TABLET / ORAL AB 2020-08-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211436-001 MIFEPRISTONE 300MG TABLET / ORAL AB 2020-08-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211436-001 MIFEPRISTONE 300MG TABLET / ORAL AB 2020-08-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211436-001 MIFEPRISTONE 300MG TABLET / ORAL AB 2020-08-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211436-001 MIFEPRISTONE 300MG TABLET / ORAL AB 2020-08-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211436-001 MIFEPRISTONE 300MG TABLET / ORAL AB 2020-08-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211436-001 MIFEPRISTONE 300MG TABLET / ORAL AB 2020-08-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211436-001 MIFEPRISTONE 300MG TABLET / ORAL AB 2020-08-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211436-001 MIFEPRISTONE 300MG TABLET / ORAL AB 2020-08-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211436-001 MIFEPRISTONE 300MG TABLET / ORAL AB 2020-08-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211436-001 MIFEPRISTONE 300MG TABLET / ORAL AB 2020-08-03 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211436-001 MIFEPRISTONE 300MG TABLET / ORAL AB 2020-08-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211436-001 MIFEPRISTONE 300MG TABLET / ORAL AB 2020-08-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211436-001 MIFEPRISTONE 300MG TABLET / ORAL AB 2020-08-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211436-001 MIFEPRISTONE 300MG TABLET / ORAL AB 2020-08-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211436-001 MIFEPRISTONE 300MG TABLET / ORAL AB 2020-08-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211436-001 MIFEPRISTONE 300MG TABLET / ORAL AB 2020-08-03 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211436-001 MIFEPRISTONE 300MG TABLET / ORAL AB 2020-08-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211436-001 MIFEPRISTONE 300MG TABLET / ORAL AB 2020-08-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211436-001 MIFEPRISTONE 300MG TABLET / ORAL AB 2020-08-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211436-001 MIFEPRISTONE 300MG TABLET / ORAL AB 2020-08-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211436-001 MIFEPRISTONE 300MG TABLET / ORAL AB 2020-08-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211436-001 MIFEPRISTONE 300MG TABLET / ORAL AB 2020-08-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211436-001 MIFEPRISTONE 300MG TABLET / ORAL AB 2020-08-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211436-001 MIFEPRISTONE 300MG TABLET / ORAL AB 2020-08-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211436-001 MIFEPRISTONE 300MG TABLET / ORAL AB 2020-08-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211436-001 MIFEPRISTONE 300MG TABLET / ORAL AB 2020-08-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211436-001 MIFEPRISTONE 300MG TABLET / ORAL AB 2020-08-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211436-001 MIFEPRISTONE 300MG TABLET / ORAL AB 2020-08-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211436-001 MIFEPRISTONE 300MG TABLET / ORAL AB 2020-08-03 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211436-001 MIFEPRISTONE 300MG TABLET / ORAL AB 2020-08-03 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211436-001 PC 2024-07-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211436-001 PC 2024-07-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211436-001 PC 2024-07-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211436-001 PC 2024-07-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211436-001 PC 2024-07-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211436-001 PC 2024-07-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211436-001 PC 2024-07-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211436-001 PC 2024-07-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211436-001 PC 2024-07-17 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211436-001 PC 2024-07-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211436-001 PC 2024-07-17 1c564ffb4f44…
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 Mifepristone MIFEPRISTONE Actavis Pharma, Inc. 5e09acc0-fd26-4722-b8b3-46e560390d47 2022-02-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 211436 application number: ANDA211436
Documents# Document, Submission type, Date table Document Submission type Date 56497 ORIG 2018-11-16