Application 017628
- Type
- NDA
- Sponsor
- ORTHO MCNEIL JANSSEN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TOLECTIN | TOLMETIN SODIUM | TABLET;ORAL | EQ 200MG BASE | Yes | No |
| 002 | TOLECTIN 600 | TOLMETIN SODIUM | TABLET;ORAL | EQ 600MG BASE | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N017628-001 | TOLECTIN | TOLMETIN SODIUM | EQ 200MG BASE | TABLET / ORAL | RLD, Approved before 1982 | ||
| N017628-002 | TOLECTIN 600 | TOLMETIN SODIUM | EQ 600MG BASE | TABLET / ORAL | RLD | 1989-03-08 |
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 | N017628-001 | TOLECTIN | EQ 200MG BASE | TABLET / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N017628-002 | TOLECTIN 600 | EQ 600MG BASE | TABLET / ORAL | RLD | 1989-03-08 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N017628-001 | TOLECTIN | EQ 200MG BASE | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N017628-002 | TOLECTIN 600 | EQ 600MG BASE | TABLET / ORAL | RLD | 1989-03-08 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N017628-001 | TOLECTIN | EQ 200MG BASE | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N017628-002 | TOLECTIN 600 | EQ 600MG BASE | TABLET / ORAL | RLD | 1989-03-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017628-001 | TOLECTIN | EQ 200MG BASE | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017628-002 | TOLECTIN 600 | EQ 600MG BASE | TABLET / ORAL | RLD | 1989-03-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N017628-001 | TOLECTIN | EQ 200MG BASE | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N017628-002 | TOLECTIN 600 | EQ 600MG BASE | TABLET / ORAL | RLD | 1989-03-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017628-001 | TOLECTIN | EQ 200MG BASE | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017628-002 | TOLECTIN 600 | EQ 600MG BASE | TABLET / ORAL | RLD | 1989-03-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017628-001 | TOLECTIN | EQ 200MG BASE | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017628-002 | TOLECTIN 600 | EQ 600MG BASE | TABLET / ORAL | RLD | 1989-03-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017628-001 | TOLECTIN | EQ 200MG BASE | TABLET / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017628-002 | TOLECTIN 600 | EQ 600MG BASE | TABLET / ORAL | RLD | 1989-03-08 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017628-001 | TOLECTIN | EQ 200MG BASE | TABLET / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017628-002 | TOLECTIN 600 | EQ 600MG BASE | TABLET / ORAL | RLD | 1989-03-08 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017628-001 | TOLECTIN | EQ 200MG BASE | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017628-002 | TOLECTIN 600 | EQ 600MG BASE | TABLET / ORAL | RLD | 1989-03-08 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017628-001 | TOLECTIN | EQ 200MG BASE | TABLET / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017628-002 | TOLECTIN 600 | EQ 600MG BASE | TABLET / ORAL | RLD | 1989-03-08 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N017628-001 | TOLECTIN | EQ 200MG BASE | TABLET / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N017628-002 | TOLECTIN 600 | EQ 600MG BASE | TABLET / ORAL | RLD | 1989-03-08 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N017628-001 | TOLECTIN | EQ 200MG BASE | TABLET / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N017628-002 | TOLECTIN 600 | EQ 600MG BASE | TABLET / ORAL | RLD | 1989-03-08 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N017628-001 | TOLECTIN | EQ 200MG BASE | TABLET / ORAL | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N017628-002 | TOLECTIN 600 | EQ 600MG BASE | TABLET / ORAL | RLD | 1989-03-08 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N017628-001 | TOLECTIN | EQ 200MG BASE | TABLET / ORAL | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N017628-002 | TOLECTIN 600 | EQ 600MG BASE | TABLET / ORAL | RLD | 1989-03-08 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N017628-001 | TOLECTIN | EQ 200MG BASE | TABLET / ORAL | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N017628-002 | TOLECTIN 600 | EQ 600MG BASE | TABLET / ORAL | RLD | 1989-03-08 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N017628-001 | TOLECTIN | EQ 200MG BASE | TABLET / ORAL | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N017628-002 | TOLECTIN 600 | EQ 600MG BASE | TABLET / ORAL | RLD | 1989-03-08 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N017628-001 | TOLECTIN | EQ 200MG BASE | TABLET / ORAL | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N017628-002 | TOLECTIN 600 | EQ 600MG BASE | TABLET / ORAL | RLD | 1989-03-08 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N017628-001 | TOLECTIN | EQ 200MG BASE | TABLET / ORAL | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N017628-002 | TOLECTIN 600 | EQ 600MG BASE | TABLET / ORAL | RLD | 1989-03-08 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N017628-001 | TOLECTIN | EQ 200MG BASE | TABLET / ORAL | Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N017628-002 | TOLECTIN 600 | EQ 600MG BASE | TABLET / ORAL | 1989-03-08 | 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 |
|---|---|---|---|---|---|---|
| Tolmetin Sodium | TOLMETIN SODIUM | Chartwell RX, LLC | 66fa5e73-477c-4bbc-b7d3-f4a69aad4460 | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | TOLMETIN SODIUM |
| Tolmetin Sodium | TOLMETIN SODIUM | Lifsa Drugs LLC | 7b26321c-4797-4664-a162-e29de4b8dd93 | 2026-05-07 | Boxed warning, Warnings, Adverse reactions | TOLMETIN SODIUM |
| TOLMETIN SODIUM | TOLMETIN SODIUM | Galt Pharmaceuticals, LLC | 0a97800f-706d-4787-98fe-08dadf9c4d5f | 2026-03-22 | Boxed warning, Warnings, Adverse reactions | TOLMETIN SODIUM |
| Tolectin | TOLMETIN SODIUM | Poly Pharmaceuticals, Inc. | 15467b19-e43a-5be9-e063-6294a90a3cca | 2025-12-30 | Boxed warning, Warnings, Adverse reactions | Tolectin TOLMETIN SODIUM |
| Tolmetin Sodium | TOLMETIN SODIUM | Atland Pharmaceuticals, LLC | e6150446-c5ef-4437-b488-067876649fcc | 2025-03-31 | Boxed warning, Warnings, Adverse reactions | TOLMETIN SODIUM |
| Tolmetin Sodium | TOLMETIN SODIUM | Atland Pharmaceuticals, LLC | 41b7704e-25a1-45e8-93c0-9ac2f0effef9 | 2025-03-24 | Boxed warning, Warnings, Adverse reactions | TOLMETIN SODIUM |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.