Application 040619
- Type
- ANDA
- Sponsor
- ECI PHARMS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 003 | METHIMAZOLE | METHIMAZOLE | TABLET;ORAL | 15MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040619-003 | METHIMAZOLE | METHIMAZOLE | 15MG | TABLET / ORAL | 2005-07-12 |
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 | 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 | A040619-003 | METHIMAZOLE | 15MG | TABLET / ORAL | 2005-07-12 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040619-003 | METHIMAZOLE | 15MG | TABLET / ORAL | 2005-07-12 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040619-003 | METHIMAZOLE | 15MG | TABLET / ORAL | 2005-07-12 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040619-003 | METHIMAZOLE | 15MG | TABLET / ORAL | 2005-07-12 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040619-003 | METHIMAZOLE | 15MG | TABLET / ORAL | 2005-07-12 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040619-003 | METHIMAZOLE | 15MG | TABLET / ORAL | 2005-07-12 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040619-003 | METHIMAZOLE | 15MG | TABLET / ORAL | 2005-07-12 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040619-003 | METHIMAZOLE | 15MG | TABLET / ORAL | 2005-07-12 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040619-003 | METHIMAZOLE | 15MG | TABLET / ORAL | 2005-07-12 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A040619-003 | METHIMAZOLE | 15MG | TABLET / ORAL | 2005-07-12 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040619-003 | METHIMAZOLE | 15MG | TABLET / ORAL | 2005-07-12 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040619-003 | METHIMAZOLE | 15MG | TABLET / ORAL | 2005-07-12 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040619-003 | METHIMAZOLE | 15MG | TABLET / ORAL | 2005-07-12 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A040619-003 | METHIMAZOLE | 15MG | TABLET / ORAL | 2005-07-12 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040619-003 | METHIMAZOLE | 15MG | TABLET / ORAL | 2005-07-12 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A040619-003 | METHIMAZOLE | 15MG | TABLET / ORAL | 2005-07-12 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A040619-003 | METHIMAZOLE | 15MG | TABLET / ORAL | 2005-07-12 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A040619-003 | METHIMAZOLE | 15MG | TABLET / ORAL | 2005-07-12 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A040619-003 | METHIMAZOLE | 15MG | TABLET / ORAL | 2005-07-12 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A040619-003 | METHIMAZOLE | 15MG | TABLET / ORAL | 2005-07-12 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040619-003 | METHIMAZOLE | 15MG | TABLET / ORAL | 2005-07-12 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A040619-003 | METHIMAZOLE | 15MG | TABLET / ORAL | 2005-07-12 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A040619-003 | METHIMAZOLE | 15MG | TABLET / ORAL | 2005-07-12 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A040619-003 | METHIMAZOLE | 15MG | TABLET / ORAL | 2005-07-12 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A040619-003 | METHIMAZOLE | 15MG | TABLET / ORAL | 2005-07-12 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A040619-003 | METHIMAZOLE | 15MG | TABLET / ORAL | 2005-07-12 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A040619-003 | METHIMAZOLE | 15MG | TABLET / ORAL | 2005-07-12 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A040619-003 | METHIMAZOLE | 15MG | TABLET / ORAL | 2005-07-12 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A040619-003 | METHIMAZOLE | 15MG | TABLET / ORAL | 2005-07-12 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A040619-003 | METHIMAZOLE | 15MG | TABLET / ORAL | 2005-07-12 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A040619-003 | METHIMAZOLE | 15MG | TABLET / ORAL | 2005-07-12 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A040619-003 | METHIMAZOLE | 15MG | TABLET / ORAL | 2005-07-12 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A040619-003 | METHIMAZOLE | 15MG | TABLET / ORAL | 2005-07-12 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A040619-003 | METHIMAZOLE | 15MG | TABLET / ORAL | 2005-07-12 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A040619-003 | METHIMAZOLE | 15MG | TABLET / ORAL | 2005-07-12 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A040619-003 | METHIMAZOLE | 15MG | TABLET / ORAL | 2005-07-12 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A040619-003 | METHIMAZOLE | 15MG | TABLET / ORAL | 2005-07-12 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A040619-003 | METHIMAZOLE | 15MG | TABLET / ORAL | 2005-07-12 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A040619-003 | METHIMAZOLE | 15MG | TABLET / ORAL | 2005-07-12 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A040619-003 | METHIMAZOLE | 15MG | TABLET / ORAL | 2005-07-12 | cb3db0bc1861… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Methimazole | METHIMAZOLE | REMEDYREPACK INC. | b53f84ac-4263-478c-883d-aca7ab44fef5 | 2026-07-07 | Warnings, Adverse reactions | Methimazole METHIMAZOLE |
| Methimazole | METHIMAZOLE | REMEDYREPACK INC. | 2c6a9c70-4ed6-4f05-bc3d-e8e7aca57c2b | 2026-07-06 | Warnings, Adverse reactions | Methimazole METHIMAZOLE |
| Methimazole | METHIMAZOLE | Preferred Pharmaceuticals Inc. | c1e6f1ee-238c-466e-b223-3c3f63dac9ed | 2026-06-23 | Warnings, Adverse reactions | Methimazole METHIMAZOLE |
| Methimazole | METHIMAZOLE | Preferred Pharmaceuticals Inc. | 244d76f1-98e6-4305-8768-b104f6a4be07 | 2026-06-23 | Warnings, Adverse reactions | Methimazole METHIMAZOLE |
| Methimazole | METHIMAZOLE | AvKARE | 545381b6-e9e9-de1e-e063-6294a90a9a97 | 2026-06-15 | Warnings, Adverse reactions | Methimazole METHIMAZOLE |
| Methimazole | METHIMAZOLE | Chartwell RX, LLC | 5b25e346-11b6-44ed-89f9-ab927232ac19 | 2026-03-10 | Warnings, Adverse reactions | Methimazole METHIMAZOLE |
| Methimazole | METHIMAZOLE | AiPing Pharmaceutical, Inc. | 06bb4bcc-5e47-48b6-a76c-648f846704e8 | 2026-02-07 | Warnings, Adverse reactions | Methimazole METHIMAZOLE |
| Methimazole | METHIMAZOLE | Preferred Pharmaceuticals Inc. | 253088bf-00f2-489b-984a-682ef9d89e90 | 2026-01-28 | Warnings, Adverse reactions | Methimazole METHIMAZOLE |
| methimazole | METHIMAZOLE | Coupler LLC | 490f04db-cb51-bde7-e063-6394a90a5546 | 2026-01-23 | Warnings, Adverse reactions | methimazole METHIMAZOLE |
| methimazole | METHIMAZOLE | Coupler LLC | 490f168f-c703-5497-e063-6294a90ade87 | 2026-01-23 | Warnings, Adverse reactions | methimazole METHIMAZOLE |
| Methimazole | METHIMAZOLE | Bryant Ranch Prepack | afa2cecc-3fef-4372-8d1e-6bbb06d41b23 | 2025-12-03 | Warnings, Adverse reactions | Methimazole METHIMAZOLE |
| Methimazole | METHIMAZOLE | Bryant Ranch Prepack | 3f65518b-33da-48d8-9af2-2a750400b401 | 2025-12-03 | Warnings, Adverse reactions | Methimazole METHIMAZOLE |
| Methimazole | METHIMAZOLE | Bryant Ranch Prepack | d05f7950-84cd-413f-9256-4c0977818d25 | 2025-11-06 | Warnings, Adverse reactions | Methimazole METHIMAZOLE |
| Methimazole | METHIMAZOLE | Bryant Ranch Prepack | 1f6970fb-a549-47b0-b812-48109521d713 | 2025-11-06 | Warnings, Adverse reactions | Methimazole METHIMAZOLE |
| Methimazole | METHIMAZOLE | AvPAK | 4116774b-6c2b-2c74-e063-6394a90a4955 | 2025-10-13 | Warnings, Adverse reactions | Methimazole METHIMAZOLE |
| Methimazole | METHIMAZOLE | Macleods Pharmaceuticals Limited | 6f08df05-cc29-45ef-8f6e-12272bfbb0d7 | 2025-09-25 | Warnings, Adverse reactions | Methimazole METHIMAZOLE |
| methimazole | METHIMAZOLE | Viona Pharmaceuticals Inc. | 05a8fed7-f805-4c59-8840-630174b6d130 | 2025-09-10 | Warnings, Adverse reactions | methimazole METHIMAZOLE |
| Methimazole | METHIMAZOLE | Proficient Rx LP | e921f23b-a9bf-4313-9cfa-f0b29c06f72a | 2025-07-01 | Warnings, Adverse reactions | Methimazole METHIMAZOLE |
| Methimazole | METHIMAZOLE | Preferred Pharmaceuticals Inc. | c063f4c0-d5fe-4b28-b14d-78f73cd7f2c3 | 2025-06-02 | Warnings, Adverse reactions | Methimazole METHIMAZOLE |
| Methimazole | METHIMAZOLE | Bryant Ranch Prepack | f74a8e69-79a1-4061-b42f-447e0780c04f | 2025-05-13 | Warnings, Adverse reactions | Methimazole METHIMAZOLE |