Application 019204
- Type
- NDA
- Sponsor
- ABBVIE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CARTROL | CARTEOLOL HYDROCHLORIDE | TABLET;ORAL | 2.5MG | No | No |
| 002 | CARTROL | CARTEOLOL HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 003 | CARTROL | CARTEOLOL HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019204-001 | CARTROL | CARTEOLOL HYDROCHLORIDE | 2.5MG | TABLET / ORAL | 1988-12-28 | ||
| N019204-002 | CARTROL | CARTEOLOL HYDROCHLORIDE | 5MG | TABLET / ORAL | 1988-12-28 | ||
| N019204-003 | CARTROL | CARTEOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | 1988-12-28 |
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 | N019204-001 | CARTROL | 2.5MG | TABLET / ORAL | 1988-12-28 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N019204-002 | CARTROL | 5MG | TABLET / ORAL | 1988-12-28 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N019204-003 | CARTROL | 10MG | TABLET / ORAL | 1988-12-28 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N019204-001 | CARTROL | 2.5MG | TABLET / ORAL | 1988-12-28 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N019204-002 | CARTROL | 5MG | TABLET / ORAL | 1988-12-28 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N019204-003 | CARTROL | 10MG | TABLET / ORAL | 1988-12-28 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N019204-001 | CARTROL | 2.5MG | TABLET / ORAL | 1988-12-28 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N019204-002 | CARTROL | 5MG | TABLET / ORAL | 1988-12-28 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N019204-003 | CARTROL | 10MG | TABLET / ORAL | 1988-12-28 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N019204-001 | CARTROL | 2.5MG | TABLET / ORAL | 1988-12-28 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N019204-002 | CARTROL | 5MG | TABLET / ORAL | 1988-12-28 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N019204-003 | CARTROL | 10MG | TABLET / ORAL | 1988-12-28 | 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 |
|---|---|---|---|---|---|---|
| Carteolol Hydrochloride | CARTEOLOL HYDROCHLORIDE | Sandoz Inc | 571fe550-399d-4296-835c-37aa1ab9b409 | 2021-08-31 | Warnings, Adverse reactions | CARTEOLOL HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.