Application 040350
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METHIMAZOLE | METHIMAZOLE | TABLET;ORAL | 5MG | No | No |
| 002 | METHIMAZOLE | METHIMAZOLE | TABLET;ORAL | 10MG | No | Yes |
| 003 | METHIMAZOLE | METHIMAZOLE | TABLET;ORAL | 20MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040350-001 | METHIMAZOLE | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2000-03-29 | |
| A040350-002 | METHIMAZOLE | METHIMAZOLE | 10MG | TABLET / ORAL | AB | RS | 2000-03-29 |
| A040350-003 | METHIMAZOLE | METHIMAZOLE | 20MG | TABLET / ORAL | 2001-06-07 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040350-001 | AB |
| A040350-002 | 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 | 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 | A040350-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2000-03-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040350-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | RS | 2000-03-29 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040350-003 | METHIMAZOLE | 20MG | TABLET / ORAL | 2001-06-07 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040350-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2000-03-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040350-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | RS | 2000-03-29 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040350-003 | METHIMAZOLE | 20MG | TABLET / ORAL | 2001-06-07 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040350-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2000-03-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040350-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | RS | 2000-03-29 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040350-003 | METHIMAZOLE | 20MG | TABLET / ORAL | 2001-06-07 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040350-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2000-03-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040350-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | RS | 2000-03-29 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040350-003 | METHIMAZOLE | 20MG | TABLET / ORAL | 2001-06-07 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040350-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2000-03-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040350-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | RS | 2000-03-29 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040350-003 | METHIMAZOLE | 20MG | TABLET / ORAL | 2001-06-07 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040350-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2000-03-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040350-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | RS | 2000-03-29 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040350-003 | METHIMAZOLE | 20MG | TABLET / ORAL | 2001-06-07 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040350-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2000-03-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040350-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | RS | 2000-03-29 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040350-003 | METHIMAZOLE | 20MG | TABLET / ORAL | 2001-06-07 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040350-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2000-03-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040350-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | RS | 2000-03-29 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040350-003 | METHIMAZOLE | 20MG | TABLET / ORAL | 2001-06-07 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040350-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2000-03-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040350-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | RS | 2000-03-29 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040350-003 | METHIMAZOLE | 20MG | TABLET / ORAL | 2001-06-07 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A040350-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2000-03-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040350-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | RS | 2000-03-29 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040350-003 | METHIMAZOLE | 20MG | TABLET / ORAL | 2001-06-07 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040350-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2000-03-29 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040350-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | RS | 2000-03-29 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040350-003 | METHIMAZOLE | 20MG | TABLET / ORAL | 2001-06-07 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040350-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2000-03-29 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040350-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | RS | 2000-03-29 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040350-003 | METHIMAZOLE | 20MG | TABLET / ORAL | 2001-06-07 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040350-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2000-03-29 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040350-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | RS | 2000-03-29 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040350-003 | METHIMAZOLE | 20MG | TABLET / ORAL | 2001-06-07 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A040350-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2000-03-29 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A040350-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040350-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040350-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040350-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040350-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040350-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040350-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040350-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040350-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040350-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040350-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040350-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040350-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040350-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040350-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040350-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040350-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040350-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040350-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040350-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040350-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040350-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040350-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040350-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040350-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040350-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040350-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A040350-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040350-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040350-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A040350-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A040350-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A040350-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A040350-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A040350-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A040350-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A040350-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A040350-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A040350-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A040350-002 | AB | 1 | 782e0a99824c… |
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 | afa2cecc-3fef-4372-8d1e-6bbb06d41b23 | 2025-12-03 | Warnings, Adverse reactions | 040350 ANDA040350 |
| Methimazole | METHIMAZOLE | Bryant Ranch Prepack | 3f65518b-33da-48d8-9af2-2a750400b401 | 2025-12-03 | Warnings, Adverse reactions | 040350 ANDA040350 |
| Methimazole | METHIMAZOLE | Bryant Ranch Prepack | d05f7950-84cd-413f-9256-4c0977818d25 | 2025-11-06 | Warnings, Adverse reactions | 040350 ANDA040350 |
| Methimazole | METHIMAZOLE | Bryant Ranch Prepack | 1f6970fb-a549-47b0-b812-48109521d713 | 2025-11-06 | Warnings, Adverse reactions | 040350 ANDA040350 |
| Methimazole | METHIMAZOLE | Bryant Ranch Prepack | 94d2e57b-685f-4cfd-a5a5-129e869c794c | 2025-04-24 | Warnings, Adverse reactions | 040350 ANDA040350 |
| Methimazole | METHIMAZOLE | Bryant Ranch Prepack | a86f51a6-1ab8-48c2-a4fc-2439e9986d45 | 2025-04-24 | Warnings, Adverse reactions | 040350 ANDA040350 |
| Methimazole | METHIMAZOLE | American Health Packaging | ca252851-32f2-4eb9-b9f5-82029f0e8c20 | 2024-12-30 | Warnings, Adverse reactions | 040350 ANDA040350 60687-680 60687-669 |
| Methimazole | METHIMAZOLE | Bryant Ranch Prepack | d003a93d-da08-4993-bb72-700342ca6e65 | 2024-12-24 | Warnings, Adverse reactions | 040350 ANDA040350 63629-9251 |
| Methimazole | METHIMAZOLE | Bryant Ranch Prepack | e03d32dd-878f-43ee-b8c2-3adad98bf66c | 2024-02-21 | Warnings, Adverse reactions | 040350 ANDA040350 |
| Methimazole | METHIMAZOLE | Bryant Ranch Prepack | c511344b-cc7f-499b-bb21-5b2312ff311e | 2023-02-20 | Warnings, Adverse reactions | 040350 ANDA040350 63629-9249 |
| Methimazole | METHIMAZOLE | Bryant Ranch Prepack | 6bdf42f6-0ce6-4e05-8962-0019fc7c65a2 | 2023-02-17 | Warnings, Adverse reactions | 040350 ANDA040350 63629-9250 |
| Methimazole | METHIMAZOLE | Strides Pharma Science Limited | 0f5fb0a4-feb9-4b86-9a93-b2c84cfc082f | 2022-04-22 | Warnings, Adverse reactions | 040350 ANDA040350 64380-213 64380-212 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42254-008 | Methimazole | methimazole | Rebel Distributors Corp. | ANDA | Current |
| 42254-009 | Methimazole | methimazole | Rebel Distributors Corp. | ANDA | Current |
| 49884-640 | Methimazole | methimazole | Par Pharmaceutical | ANDA | Current |
| 49884-640 | Methimazole | methimazole | Par Pharmaceutical | ANDA | Current |
| 49884-640 | Methimazole | methimazole | Par Pharmaceutical | ANDA | Current |
| 49884-640 | Methimazole | methimazole | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-640 | Methimazole | methimazole | Par Pharmaceutical | ANDA | Current |
| 49884-641 | Methimazole | methimazole | Par Pharmaceutical | ANDA | Current |
| 49884-641 | Methimazole | methimazole | Par Pharmaceutical | ANDA | Current |
| 49884-641 | Methimazole | methimazole | Par Pharmaceutical | ANDA | Current |
| 49884-641 | Methimazole | methimazole | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-641 | Methimazole | methimazole | Par Pharmaceutical | ANDA | Current |
| 50090-2366 | Methimazole | methimazole | A-S Medication Solutions | ANDA | Current |
| 50090-2366 | Methimazole | methimazole | A-S Medication Solutions | ANDA | Current |
| 50090-3334 | Methimazole | methimazole | A-S Medication Solutions | ANDA | Current |
| 50090-3334 | Methimazole | methimazole | A-S Medication Solutions | ANDA | Current |
| 53808-0850 | Methimazole | methimazole | State of Florida DOH Central Pharmacy | ANDA | Current |
| 60687-357 | Methimazole | methimazole | American Health Packaging | ANDA | Current |
| 60687-357 | Methimazole | methimazole | American Health Packaging | ANDA | Current |
| 60687-357 | Methimazole | Methimazole | American Health Packaging | ANDA | Current |
| 60687-357 | Methimazole | Methimazole | American Health Packaging | ANDA | Current |
| 60687-370 | Methimazole | methimazole | American Health Packaging | ANDA | Current |
| 60687-370 | Methimazole | methimazole | American Health Packaging | ANDA | Current |
| 60687-370 | Methimazole | Methimazole | American Health Packaging | ANDA | Current |
| 60687-370 | Methimazole | Methimazole | American Health Packaging | ANDA | Current |
| 60687-669 | Methimazole | methimazole | American Health Packaging | ANDA | Current |
| 60687-680 | Methimazole | methimazole | American Health Packaging | ANDA | Current |
| 63629-2224 | Methimazole | methimazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-2224 | Methimazole | methimazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-2224 | Methimazole | methimazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-2225 | Methimazole | methimazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-2225 | Methimazole | methimazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-2225 | Methimazole | methimazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-4331 | Methimazole | methimazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-6408 | Methimazole | methimazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-6408 | Methimazole | methimazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-6408 | Methimazole | methimazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-9137 | Methimazole | methimazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-9137 | Methimazole | methimazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-9137 | Methimazole | methimazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-9249 | Methimazole | methimazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-9249 | Methimazole | methimazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-9250 | Methimazole | methimazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-9250 | Methimazole | methimazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-9250 | Methimazole | methimazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-9251 | Methimazole | methimazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-9251 | Methimazole | methimazole | Bryant Ranch Prepack | ANDA | Current |
| 64380-212 | Methimazole | methimazole | Strides Pharma Science Limited | ANDA | Current |
| 64380-212 | Methimazole | methimazole | Strides Pharma Science Limited | ANDA | Current |
| 64380-213 | Methimazole | methimazole | Strides Pharma Science Limited | ANDA | Current |
| 64380-213 | Methimazole | methimazole | Strides Pharma Science Limited | ANDA | Current |
| 64980-260 | Methimazole | methimazole | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 64980-260 | Methimazole | methimazole | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 64980-261 | Methimazole | methimazole | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 64980-261 | Methimazole | methimazole | Rising Pharmaceuticals, Inc. | ANDA | Current |