Home Applications 209827 Application 209827
Type ANDA
Sponsor MACLEODS PHARMS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 METHIMAZOLE METHIMAZOLE TABLET;ORAL 5MG No No 002 METHIMAZOLE METHIMAZOLE TABLET;ORAL 10MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209827-001 METHIMAZOLE METHIMAZOLE 5MG TABLET / ORAL AB 2023-05-24 A209827-002 METHIMAZOLE METHIMAZOLE 10MG TABLET / ORAL AB 2023-05-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 44 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 A209827-001 METHIMAZOLE 5MG TABLET / ORAL AB 2023-05-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209827-002 METHIMAZOLE 10MG TABLET / ORAL AB 2023-05-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209827-001 METHIMAZOLE 5MG TABLET / ORAL AB 2023-05-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209827-002 METHIMAZOLE 10MG TABLET / ORAL AB 2023-05-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209827-001 METHIMAZOLE 5MG TABLET / ORAL AB 2023-05-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209827-002 METHIMAZOLE 10MG TABLET / ORAL AB 2023-05-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209827-001 METHIMAZOLE 5MG TABLET / ORAL AB 2023-05-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209827-002 METHIMAZOLE 10MG TABLET / ORAL AB 2023-05-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209827-001 METHIMAZOLE 5MG TABLET / ORAL AB 2023-05-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209827-002 METHIMAZOLE 10MG TABLET / ORAL AB 2023-05-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209827-001 METHIMAZOLE 5MG TABLET / ORAL AB 2023-05-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209827-002 METHIMAZOLE 10MG TABLET / ORAL AB 2023-05-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209827-001 METHIMAZOLE 5MG TABLET / ORAL AB 2023-05-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209827-002 METHIMAZOLE 10MG TABLET / ORAL AB 2023-05-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209827-001 METHIMAZOLE 5MG TABLET / ORAL AB 2023-05-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209827-002 METHIMAZOLE 10MG TABLET / ORAL AB 2023-05-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209827-001 METHIMAZOLE 5MG TABLET / ORAL AB 2023-05-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209827-002 METHIMAZOLE 10MG TABLET / ORAL AB 2023-05-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209827-001 METHIMAZOLE 5MG TABLET / ORAL AB 2023-05-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209827-002 METHIMAZOLE 10MG TABLET / ORAL AB 2023-05-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209827-001 METHIMAZOLE 5MG TABLET / ORAL AB 2023-05-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209827-002 METHIMAZOLE 10MG TABLET / ORAL AB 2023-05-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209827-001 METHIMAZOLE 5MG TABLET / ORAL AB 2023-05-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209827-002 METHIMAZOLE 10MG TABLET / ORAL AB 2023-05-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209827-001 METHIMAZOLE 5MG TABLET / ORAL AB 2023-05-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209827-002 METHIMAZOLE 10MG TABLET / ORAL AB 2023-05-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209827-001 METHIMAZOLE 5MG TABLET / ORAL AB 2023-05-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A209827-002 METHIMAZOLE 10MG TABLET / ORAL AB 2023-05-24 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209827-001 METHIMAZOLE 5MG TABLET / ORAL AB 2023-05-24 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209827-002 METHIMAZOLE 10MG TABLET / ORAL AB 2023-05-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209827-001 METHIMAZOLE 5MG TABLET / ORAL AB 2023-05-24 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A209827-002 METHIMAZOLE 10MG TABLET / ORAL AB 2023-05-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209827-001 METHIMAZOLE 5MG TABLET / ORAL AB 2023-05-24 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A209827-002 METHIMAZOLE 10MG TABLET / ORAL AB 2023-05-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209827-001 METHIMAZOLE 5MG TABLET / ORAL AB 2023-05-24 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209827-002 METHIMAZOLE 10MG TABLET / ORAL AB 2023-05-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209827-001 METHIMAZOLE 5MG TABLET / ORAL AB 2023-05-24 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209827-002 METHIMAZOLE 10MG TABLET / ORAL AB 2023-05-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209827-001 METHIMAZOLE 5MG TABLET / ORAL AB 2023-05-24 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209827-002 METHIMAZOLE 10MG TABLET / ORAL AB 2023-05-24 a67488948f0b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 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 Methimazole METHIMAZOLE Macleods Pharmaceuticals Limited 6f08df05-cc29-45ef-8f6e-12272bfbb0d7 2025-09-25 Warnings, Adverse reactions Exact identifier application applno (ANDA): 209827 application number: ANDA209827