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 | Bryant Ranch Prepack | 94d2e57b-685f-4cfd-a5a5-129e869c794c | 2025-04-24 | Warnings, Adverse reactions | Methimazole METHIMAZOLE |
| Methimazole | METHIMAZOLE | Bryant Ranch Prepack | a86f51a6-1ab8-48c2-a4fc-2439e9986d45 | 2025-04-24 | Warnings, Adverse reactions | Methimazole METHIMAZOLE |
| Methimazole | METHIMAZOLE | Rising Pharma Holdings, Inc. | 289ec852-176e-41aa-9f9a-b1f9b4196771 | 2025-03-06 | Warnings, Adverse reactions | Methimazole METHIMAZOLE |
| Methimazole | METHIMAZOLE | American Health Packaging | ca252851-32f2-4eb9-b9f5-82029f0e8c20 | 2024-12-30 | Warnings, Adverse reactions | Methimazole METHIMAZOLE |
| Methimazole | METHIMAZOLE | Bryant Ranch Prepack | d003a93d-da08-4993-bb72-700342ca6e65 | 2024-12-24 | Warnings, Adverse reactions | Methimazole METHIMAZOLE |
| Methimazole | METHIMAZOLE | Golden State Medical Supply, Inc. | 4eff3321-2fce-4bab-94af-7b16e333beed | 2024-09-24 | Warnings, Adverse reactions | Methimazole METHIMAZOLE |
| Methimazole | METHIMAZOLE | NORTHSTAR RX LLC | 923fec30-90fd-4bd5-beb3-f2ca4fc171ee | 2024-06-28 | Warnings, Adverse reactions | Methimazole METHIMAZOLE |
| Methimazole | METHIMAZOLE | Upsher-Smith Laboratories, LLC | 2185e6e0-7c21-4348-a7b4-d898f50a0184 | 2024-03-22 | Warnings, Adverse reactions | Methimazole METHIMAZOLE |
| Methimazole | METHIMAZOLE | Bionpharma Inc. | 141a91d5-b56e-06d6-e063-6394a90a11ba | 2024-03-20 | Warnings, Adverse reactions | Methimazole METHIMAZOLE |
| Methimazole | METHIMAZOLE | Bryant Ranch Prepack | e03d32dd-878f-43ee-b8c2-3adad98bf66c | 2024-02-21 | Warnings, Adverse reactions | Methimazole METHIMAZOLE |
| methimazole | METHIMAZOLE | SQUARE PHARMACEUTICALS PLC. | 33e065a1-dd4e-43f9-a841-f96e633fc850 | 2024-02-20 | Warnings, Adverse reactions | methimazole METHIMAZOLE |
| Methimazole | METHIMAZOLE | Bryant Ranch Prepack | 381052c4-891c-4ae4-b63e-65229126cbca | 2023-11-10 | Warnings, Adverse reactions | Methimazole METHIMAZOLE |
| Methimazole | METHIMAZOLE | Bryant Ranch Prepack | 3ca961ca-cbf2-4a73-8c81-4205e01b2695 | 2023-11-08 | Warnings, Adverse reactions | Methimazole METHIMAZOLE |
| Methimazole | METHIMAZOLE | A-S Medication Solutions | 87eb663e-5dd3-4a7a-8b28-7e19c5ad1173 | 2023-06-29 | Warnings, Adverse reactions | Methimazole METHIMAZOLE |
| Methimazole | METHIMAZOLE | Bryant Ranch Prepack | c511344b-cc7f-499b-bb21-5b2312ff311e | 2023-02-20 | Warnings, Adverse reactions | Methimazole METHIMAZOLE |
| Methimazole | METHIMAZOLE | Bryant Ranch Prepack | 6bdf42f6-0ce6-4e05-8962-0019fc7c65a2 | 2023-02-17 | Warnings, Adverse reactions | Methimazole METHIMAZOLE |
| Methimazole | METHIMAZOLE | Strides Pharma Science Limited | 0f5fb0a4-feb9-4b86-9a93-b2c84cfc082f | 2022-04-22 | Warnings, Adverse reactions | Methimazole METHIMAZOLE |
| Methimazole | METHIMAZOLE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 8c3a9aaa-cdde-404b-9af6-5a88ef649aac | 2022-03-24 | Warnings, Adverse reactions | Methimazole METHIMAZOLE |