Application 007517
- Type
- NDA
- Sponsor
- KING PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | TAPAZOLE | METHIMAZOLE | TABLET;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 004 | TAPAZOLE | METHIMAZOLE | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N007517-002 | TAPAZOLE | METHIMAZOLE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N007517-004 | TAPAZOLE | METHIMAZOLE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N007517-002 | TAPAZOLE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N007517-004 | TAPAZOLE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N007517-002 | TAPAZOLE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N007517-004 | TAPAZOLE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N007517-002 | TAPAZOLE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N007517-004 | TAPAZOLE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N007517-002 | TAPAZOLE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N007517-004 | TAPAZOLE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N007517-002 | TAPAZOLE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N007517-004 | TAPAZOLE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N007517-002 | TAPAZOLE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N007517-004 | TAPAZOLE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N007517-002 | TAPAZOLE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N007517-004 | TAPAZOLE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N007517-002 | TAPAZOLE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N007517-004 | TAPAZOLE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N007517-002 | TAPAZOLE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N007517-004 | TAPAZOLE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N007517-002 | TAPAZOLE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N007517-004 | TAPAZOLE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N007517-002 | TAPAZOLE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N007517-004 | TAPAZOLE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N007517-002 | TAPAZOLE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N007517-004 | TAPAZOLE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N007517-002 | TAPAZOLE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N007517-004 | TAPAZOLE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N007517-002 | TAPAZOLE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N007517-004 | TAPAZOLE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N007517-002 | TAPAZOLE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N007517-004 | TAPAZOLE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N007517-002 | TAPAZOLE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N007517-004 | TAPAZOLE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N007517-002 | TAPAZOLE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N007517-004 | TAPAZOLE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N007517-002 | TAPAZOLE | 5MG | TABLET / ORAL | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N007517-004 | TAPAZOLE | 10MG | TABLET / ORAL | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N007517-002 | TAPAZOLE | 5MG | TABLET / ORAL | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N007517-004 | TAPAZOLE | 10MG | TABLET / ORAL | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N007517-002 | TAPAZOLE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD, Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N007517-004 | TAPAZOLE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD, Approved before 1982 | 74a2ff9319b5… |
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 | f74a8e69-79a1-4061-b42f-447e0780c04f | 2025-05-13 | Warnings, Adverse reactions | METHIMAZOLE |
| Methimazole | METHIMAZOLE | Bryant Ranch Prepack | 94d2e57b-685f-4cfd-a5a5-129e869c794c | 2025-04-24 | Warnings, Adverse reactions | METHIMAZOLE |
| Methimazole | METHIMAZOLE | Bryant Ranch Prepack | a86f51a6-1ab8-48c2-a4fc-2439e9986d45 | 2025-04-24 | Warnings, Adverse reactions | METHIMAZOLE |
| Methimazole | METHIMAZOLE | Rising Pharma Holdings, Inc. | 289ec852-176e-41aa-9f9a-b1f9b4196771 | 2025-03-06 | Warnings, Adverse reactions | METHIMAZOLE |
| Methimazole | METHIMAZOLE | American Health Packaging | ca252851-32f2-4eb9-b9f5-82029f0e8c20 | 2024-12-30 | Warnings, Adverse reactions | METHIMAZOLE |
| Methimazole | METHIMAZOLE | Bryant Ranch Prepack | d003a93d-da08-4993-bb72-700342ca6e65 | 2024-12-24 | Warnings, Adverse reactions | METHIMAZOLE |
| Methimazole | METHIMAZOLE | Golden State Medical Supply, Inc. | 4eff3321-2fce-4bab-94af-7b16e333beed | 2024-09-24 | Warnings, Adverse reactions | METHIMAZOLE |
| Methimazole | METHIMAZOLE | NORTHSTAR RX LLC | 923fec30-90fd-4bd5-beb3-f2ca4fc171ee | 2024-06-28 | Warnings, Adverse reactions | METHIMAZOLE |
| Methimazole | METHIMAZOLE | Upsher-Smith Laboratories, LLC | 2185e6e0-7c21-4348-a7b4-d898f50a0184 | 2024-03-22 | Warnings, Adverse reactions | METHIMAZOLE |
| Methimazole | METHIMAZOLE | Bionpharma Inc. | 141a91d5-b56e-06d6-e063-6394a90a11ba | 2024-03-20 | Warnings, Adverse reactions | METHIMAZOLE |
| Methimazole | METHIMAZOLE | Bryant Ranch Prepack | e03d32dd-878f-43ee-b8c2-3adad98bf66c | 2024-02-21 | Warnings, Adverse reactions | METHIMAZOLE |
| methimazole | METHIMAZOLE | SQUARE PHARMACEUTICALS PLC. | 33e065a1-dd4e-43f9-a841-f96e633fc850 | 2024-02-20 | Warnings, Adverse reactions | METHIMAZOLE |
| Methimazole | METHIMAZOLE | Bryant Ranch Prepack | 381052c4-891c-4ae4-b63e-65229126cbca | 2023-11-10 | Warnings, Adverse reactions | METHIMAZOLE |
| Methimazole | METHIMAZOLE | Bryant Ranch Prepack | 3ca961ca-cbf2-4a73-8c81-4205e01b2695 | 2023-11-08 | Warnings, Adverse reactions | METHIMAZOLE |
| Methimazole | METHIMAZOLE | A-S Medication Solutions | 87eb663e-5dd3-4a7a-8b28-7e19c5ad1173 | 2023-06-29 | Warnings, Adverse reactions | METHIMAZOLE |
| Methimazole | METHIMAZOLE | Bryant Ranch Prepack | c511344b-cc7f-499b-bb21-5b2312ff311e | 2023-02-20 | Warnings, Adverse reactions | METHIMAZOLE |
| Methimazole | METHIMAZOLE | Bryant Ranch Prepack | 6bdf42f6-0ce6-4e05-8962-0019fc7c65a2 | 2023-02-17 | Warnings, Adverse reactions | METHIMAZOLE |
| Methimazole | METHIMAZOLE | Strides Pharma Science Limited | 0f5fb0a4-feb9-4b86-9a93-b2c84cfc082f | 2022-04-22 | Warnings, Adverse reactions | METHIMAZOLE |
| Methimazole | METHIMAZOLE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 8c3a9aaa-cdde-404b-9af6-5a88ef649aac | 2022-03-24 | Warnings, Adverse reactions | METHIMAZOLE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 10694 | SUPPL | 2009-03-13 |