Home Applications 040411 Application 040411
Type ANDA
Sponsor CASI PHARMS INC 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 A040411-001 METHIMAZOLE METHIMAZOLE 5MG TABLET / ORAL AB 2001-03-27 A040411-002 METHIMAZOLE METHIMAZOLE 10MG TABLET / ORAL AB 2001-03-27
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 3 · 82 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 A040411-001 METHIMAZOLE 5MG TABLET / ORAL AB 2001-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040411-002 METHIMAZOLE 10MG TABLET / ORAL AB 2001-03-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040411-001 METHIMAZOLE 5MG TABLET / ORAL AB 2001-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040411-002 METHIMAZOLE 10MG TABLET / ORAL AB 2001-03-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040411-001 METHIMAZOLE 5MG TABLET / ORAL AB 2001-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040411-002 METHIMAZOLE 10MG TABLET / ORAL AB 2001-03-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040411-001 METHIMAZOLE 5MG TABLET / ORAL AB 2001-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040411-002 METHIMAZOLE 10MG TABLET / ORAL AB 2001-03-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040411-001 METHIMAZOLE 5MG TABLET / ORAL AB 2001-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040411-002 METHIMAZOLE 10MG TABLET / ORAL AB 2001-03-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040411-001 METHIMAZOLE 5MG TABLET / ORAL AB 2001-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040411-002 METHIMAZOLE 10MG TABLET / ORAL AB 2001-03-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040411-001 METHIMAZOLE 5MG TABLET / ORAL AB 2001-03-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040411-002 METHIMAZOLE 10MG TABLET / ORAL AB 2001-03-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040411-001 METHIMAZOLE 5MG TABLET / ORAL AB 2001-03-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040411-002 METHIMAZOLE 10MG TABLET / ORAL AB 2001-03-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040411-001 METHIMAZOLE 5MG TABLET / ORAL AB 2001-03-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040411-002 METHIMAZOLE 10MG TABLET / ORAL AB 2001-03-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040411-001 METHIMAZOLE 5MG TABLET / ORAL AB 2001-03-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040411-002 METHIMAZOLE 10MG TABLET / ORAL AB 2001-03-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040411-001 METHIMAZOLE 5MG TABLET / ORAL AB 2001-03-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040411-002 METHIMAZOLE 10MG TABLET / ORAL AB 2001-03-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040411-001 METHIMAZOLE 5MG TABLET / ORAL AB 2001-03-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040411-002 METHIMAZOLE 10MG TABLET / ORAL AB 2001-03-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040411-001 METHIMAZOLE 5MG TABLET / ORAL AB 2001-03-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040411-002 METHIMAZOLE 10MG TABLET / ORAL AB 2001-03-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040411-001 METHIMAZOLE 5MG TABLET / ORAL AB 2001-03-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A040411-002 METHIMAZOLE 10MG TABLET / ORAL AB 2001-03-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040411-001 METHIMAZOLE 5MG TABLET / ORAL AB 2001-03-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040411-002 METHIMAZOLE 10MG TABLET / ORAL AB 2001-03-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040411-001 METHIMAZOLE 5MG TABLET / ORAL AB 2001-03-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A040411-002 METHIMAZOLE 10MG TABLET / ORAL AB 2001-03-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040411-001 METHIMAZOLE 5MG TABLET / ORAL AB 2001-03-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A040411-002 METHIMAZOLE 10MG TABLET / ORAL AB 2001-03-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040411-001 METHIMAZOLE 5MG TABLET / ORAL AB 2001-03-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A040411-002 METHIMAZOLE 10MG TABLET / ORAL AB 2001-03-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040411-001 METHIMAZOLE 5MG TABLET / ORAL AB 2001-03-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A040411-002 METHIMAZOLE 10MG TABLET / ORAL AB 2001-03-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040411-001 METHIMAZOLE 5MG TABLET / ORAL AB 2001-03-27 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A040411-002 METHIMAZOLE 10MG TABLET / ORAL AB 2001-03-27 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 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 · 11 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0185-0205 Methimazole Methimazole Eon Labs, Inc. ANDA Current 0185-0210 Methimazole Methimazole Eon Labs, Inc. ANDA Current 0615-6500 Methimazole Methimazole NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0615-7613 Methimazole Methimazole NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 50436-7066 Methimazole Methimazole Unit Dose Services ANDA Current 62135-205 Methimazole Methimazole Chartwell RX, LLC ANDA Current 62135-205 Methimazole Methimazole Chartwell RX, LLC ANDA Current 62135-206 Methimazole Methimazole Chartwell RX, LLC ANDA Current 62135-206 Methimazole Methimazole Chartwell RX, LLC ANDA Current 68084-275 Methimazole Methimazole American Health Packaging ANDA Current 68084-276 Methimazole Methimazole American Health Packaging ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 29951 ORIG 2001-03-27