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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | N017628-001 | TOLECTIN | EQ 200MG BASE | TABLET / ORAL | RLD, Approved before 1982 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N017628-002 | TOLECTIN 600 | EQ 600MG BASE | TABLET / ORAL | RLD | 1989-03-08 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N017628-001 | TOLECTIN | EQ 200MG BASE | TABLET / ORAL | RLD, Approved before 1982 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N017628-002 | TOLECTIN 600 | EQ 600MG BASE | TABLET / ORAL | RLD | 1989-03-08 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N017628-001 | TOLECTIN | EQ 200MG BASE | TABLET / ORAL | RLD, Approved before 1982 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N017628-002 | TOLECTIN 600 | EQ 600MG BASE | TABLET / ORAL | RLD | 1989-03-08 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N017628-001 | TOLECTIN | EQ 200MG BASE | TABLET / ORAL | RLD, Approved before 1982 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N017628-002 | TOLECTIN 600 | EQ 600MG BASE | TABLET / ORAL | RLD | 1989-03-08 | 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 |
|---|---|---|---|---|---|---|
| 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.