Application 017661
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TAVIST | CLEMASTINE FUMARATE | TABLET;ORAL | 2.68MG | Yes | No |
| 002 | TAVIST-1 | CLEMASTINE FUMARATE | TABLET;ORAL | 1.34MG | No | No |
| 003 | TAVIST-1 | CLEMASTINE FUMARATE | TABLET;ORAL | 1.34MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N017661-001 | TAVIST | CLEMASTINE FUMARATE | 2.68MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N017661-002 | TAVIST-1 | CLEMASTINE FUMARATE | 1.34MG | TABLET / ORAL | Approved before 1982 | ||
| N017661-003 | TAVIST-1 | CLEMASTINE FUMARATE | 1.34MG | TABLET / ORAL | 1992-08-21 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N017661-002 | TAVIST-1 | 1.34MG | TABLET / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N017661-003 | TAVIST-1 | 1.34MG | TABLET / ORAL | 1992-08-21 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N017661-001 | TAVIST | 2.68MG | TABLET / ORAL | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N017661-002 | TAVIST-1 | 1.34MG | TABLET / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N017661-003 | TAVIST-1 | 1.34MG | TABLET / ORAL | 1992-08-21 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N017661-001 | TAVIST | 2.68MG | TABLET / ORAL | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N017661-002 | TAVIST-1 | 1.34MG | TABLET / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N017661-003 | TAVIST-1 | 1.34MG | TABLET / ORAL | 1992-08-21 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N017661-001 | TAVIST | 2.68MG | TABLET / ORAL | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N017661-002 | TAVIST-1 | 1.34MG | TABLET / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N017661-003 | TAVIST-1 | 1.34MG | TABLET / ORAL | 1992-08-21 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N017661-001 | TAVIST | 2.68MG | TABLET / ORAL | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N017661-002 | TAVIST-1 | 1.34MG | TABLET / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N017661-003 | TAVIST-1 | 1.34MG | TABLET / ORAL | 1992-08-21 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N017661-001 | TAVIST | 2.68MG | TABLET / ORAL | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N017661-002 | TAVIST-1 | 1.34MG | TABLET / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N017661-003 | TAVIST-1 | 1.34MG | TABLET / ORAL | 1992-08-21 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N017661-001 | TAVIST | 2.68MG | TABLET / ORAL | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N017661-002 | TAVIST-1 | 1.34MG | TABLET / ORAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N017661-003 | TAVIST-1 | 1.34MG | TABLET / ORAL | 1992-08-21 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N017661-001 | TAVIST | 2.68MG | TABLET / ORAL | RLD, Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N017661-002 | TAVIST-1 | 1.34MG | TABLET / ORAL | Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N017661-003 | TAVIST-1 | 1.34MG | TABLET / ORAL | 1992-08-21 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N017661-001 | TAVIST | 2.68MG | TABLET / ORAL | RLD, Approved before 1982 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N017661-002 | TAVIST-1 | 1.34MG | TABLET / ORAL | Approved before 1982 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N017661-003 | TAVIST-1 | 1.34MG | TABLET / ORAL | 1992-08-21 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N017661-001 | TAVIST | 2.68MG | TABLET / ORAL | RLD, Approved before 1982 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N017661-002 | TAVIST-1 | 1.34MG | TABLET / ORAL | Approved before 1982 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N017661-003 | TAVIST-1 | 1.34MG | TABLET / ORAL | 1992-08-21 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N017661-001 | TAVIST | 2.68MG | TABLET / ORAL | RLD, Approved before 1982 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N017661-002 | TAVIST-1 | 1.34MG | TABLET / ORAL | Approved before 1982 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N017661-003 | TAVIST-1 | 1.34MG | TABLET / ORAL | 1992-08-21 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N017661-001 | TAVIST | 2.68MG | TABLET / ORAL | RLD, Approved before 1982 | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N017661-002 | TAVIST-1 | 1.34MG | TABLET / ORAL | Approved before 1982 | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N017661-003 | TAVIST-1 | 1.34MG | TABLET / ORAL | 1992-08-21 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N017661-001 | TAVIST | 2.68MG | TABLET / ORAL | RLD, Approved before 1982 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N017661-002 | TAVIST-1 | 1.34MG | TABLET / ORAL | Approved before 1982 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N017661-003 | TAVIST-1 | 1.34MG | TABLET / ORAL | 1992-08-21 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N017661-001 | TAVIST | 2.68MG | TABLET / ORAL | RLD, Approved before 1982 | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N017661-002 | TAVIST-1 | 1.34MG | TABLET / ORAL | Approved before 1982 | c0c555d07b60… |
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 |
|---|---|---|---|---|---|---|
| Clemastine Fumarate | CLEMASTINE FUMARATE | Genus Lifesciences | cf8a3449-8bb3-4d5c-8d0d-557590e49ee5 | 2025-02-03 | Warnings, Adverse reactions | CLEMASTINE FUMARATE |
| Clemastine Fumarate | CLEMASTINE FUMARATE | Genus Lifesciences | 5c99e7af-86a5-4c17-82d5-2d4119e4fe72 | 2024-11-25 | Warnings, Adverse reactions | CLEMASTINE FUMARATE |
| CLEMASTINE FUMARATE | CLEMASTINE FUMARATE | Chartwell RX, LLC | 6663f1b0-5353-401f-b9d3-d9f69ad08fbf | 2023-07-07 | Warnings, Adverse reactions | CLEMASTINE FUMARATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.