Application 218830
- Type
- ANDA
- Sponsor
- SQUARE PHARMS PLC
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 | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A218830-001 | METHIMAZOLE | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2025-02-05 | |
| A218830-002 | METHIMAZOLE | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2025-02-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A218830-001 | AB |
| A218830-002 | 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 | A218830-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2025-02-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218830-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2025-02-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218830-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2025-02-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218830-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2025-02-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A218830-001 | METHIMAZOLE | 5MG | TABLET / ORAL | 2025-02-05 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A218830-002 | METHIMAZOLE | 10MG | TABLET / ORAL | 2025-02-05 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218830-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2025-02-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218830-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2025-02-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A218830-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2025-02-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A218830-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2025-02-05 | b8a1b40f171c… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218830-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2025-02-05 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218830-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2025-02-05 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A218830-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A218830-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218830-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218830-002 | AB | 1 | 31067a03dcf5… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218830-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218830-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A218830-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A218830-002 | AB | 1 | b8a1b40f171c… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218830-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218830-002 | AB | 1 | a50c72e98297… |
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 | Coupler LLC | 490f04db-cb51-bde7-e063-6394a90a5546 | 2026-01-23 | Warnings, Adverse reactions | 218830 ANDA218830 |
| methimazole | METHIMAZOLE | Coupler LLC | 490f168f-c703-5497-e063-6294a90ade87 | 2026-01-23 | Warnings, Adverse reactions | 218830 ANDA218830 |
| methimazole | METHIMAZOLE | Viona Pharmaceuticals Inc. | 05a8fed7-f805-4c59-8840-630174b6d130 | 2025-09-10 | Warnings, Adverse reactions | 218830 ANDA218830 |
| methimazole | METHIMAZOLE | SQUARE PHARMACEUTICALS PLC. | 33e065a1-dd4e-43f9-a841-f96e633fc850 | 2024-02-20 | Warnings, Adverse reactions | 218830 ANDA218830 |