Application 018285
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VISKEN | PINDOLOL | TABLET;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | VISKEN | PINDOLOL | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| N018285-001 | VISKEN | PINDOLOL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-09-03 | |
| N018285-002 | VISKEN | PINDOLOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-09-03 |
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UTC | 2022-10 | N018285-001 | VISKEN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-09-03 | f41ea6bd6efb… | |
| 2022-10-28 04:53 UTC | 2022-10 | N018285-002 | VISKEN | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-09-03 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N018285-001 | VISKEN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-09-03 | e64feba35796… | |
| 2022-09-29 23:25 UTC | 2022-09 | N018285-002 | VISKEN | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-09-03 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N018285-001 | VISKEN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-09-03 | cb3db0bc1861… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N018285-002 | VISKEN | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-09-03 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N018285-001 | VISKEN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-09-03 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N018285-002 | VISKEN | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-09-03 | 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 |
|---|---|---|---|---|---|---|
| Pindolol | PINDOLOL | PD-Rx Pharmaceuticals, Inc. | 0daed7b3-6017-4611-8c3a-2f390470f8bc | 2026-07-17 | Warnings, Adverse reactions | PINDOLOL |
| Pindolol | PINDOLOL | PD-Rx Pharmaceuticals, Inc. | 79a8d97b-9461-4914-bcbb-f6f64a39e5e7 | 2026-07-17 | Warnings, Adverse reactions | PINDOLOL |
| Pindolol | PINDOLOL | Bryant Ranch Prepack | 8498aead-0aef-4cd8-a191-05cae57a55e5 | 2026-05-27 | Warnings, Adverse reactions | PINDOLOL |
| Pindolol | PINDOLOL | Bryant Ranch Prepack | 22b95e96-ead9-4149-badb-7d33077e82ec | 2026-05-27 | Warnings, Adverse reactions | PINDOLOL |
| Pindolol | PINDOLOL | Sun Pharmaceutical Industries, Inc. | b331a73f-bf7b-4442-8901-36d016530279 | 2026-03-17 | Warnings, Adverse reactions | PINDOLOL |
| Pindolol | PINDOLOL | Marlex Pharmaceuticals, Inc. | e1049edf-376e-317b-e053-2995a90a2aac | 2026-02-06 | Warnings, Adverse reactions | PINDOLOL |
| Pindolol | PINDOLOL | PD-Rx Pharmaceuticals, Inc. | f91e5715-e37d-45fa-97a7-4d32fbd51060 | 2026-01-12 | Warnings, Adverse reactions | PINDOLOL |
| Pindolol | PINDOLOL | Unichem Pharmaceuticals (USA), Inc. | f529ff35-f82b-4a3a-96b4-096bfc8e81b5 | 2025-12-11 | Warnings, Adverse reactions | PINDOLOL |
| Pindolol | PINDOLOL | Westminster Pharmaceuticals, LLC | efdb0189-37b5-45d6-b92c-1157bb9df789 | 2025-11-25 | Warnings, Adverse reactions | PINDOLOL |
| Pindolol | PINDOLOL | ANI Pharmaceuticals, Inc. | 611be921-e9b6-4800-80b2-c2d4f677cdb2 | 2025-09-19 | Warnings, Adverse reactions | PINDOLOL |
| Pindolol | PINDOLOL | Bryant Ranch Prepack | 7fb36f8f-11fe-498e-8667-daeccf8b2273 | 2024-11-25 | Warnings, Adverse reactions | PINDOLOL |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.