Application 018118
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LANOXICAPS | DIGOXIN | CAPSULE;ORAL | 0.2MG | No | No |
| 002 | LANOXICAPS | DIGOXIN | CAPSULE;ORAL | 0.05MG | No | No |
| 003 | LANOXICAPS | DIGOXIN | CAPSULE;ORAL | 0.1MG | No | No |
| 004 | LANOXICAPS | DIGOXIN | CAPSULE;ORAL | 0.15MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018118-001 | LANOXICAPS | DIGOXIN | 0.2MG | CAPSULE / ORAL | 1982-07-26 | ||
| N018118-002 | LANOXICAPS | DIGOXIN | 0.05MG | CAPSULE / ORAL | 1982-07-26 | ||
| N018118-003 | LANOXICAPS | DIGOXIN | 0.1MG | CAPSULE / ORAL | 1982-07-26 | ||
| N018118-004 | LANOXICAPS | DIGOXIN | 0.15MG | CAPSULE / ORAL | 1984-09-24 |
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 | N018118-001 | LANOXICAPS | 0.2MG | CAPSULE / ORAL | 1982-07-26 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N018118-002 | LANOXICAPS | 0.05MG | CAPSULE / ORAL | 1982-07-26 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N018118-003 | LANOXICAPS | 0.1MG | CAPSULE / ORAL | 1982-07-26 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N018118-004 | LANOXICAPS | 0.15MG | CAPSULE / ORAL | 1984-09-24 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N018118-001 | LANOXICAPS | 0.2MG | CAPSULE / ORAL | 1982-07-26 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N018118-002 | LANOXICAPS | 0.05MG | CAPSULE / ORAL | 1982-07-26 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N018118-003 | LANOXICAPS | 0.1MG | CAPSULE / ORAL | 1982-07-26 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N018118-004 | LANOXICAPS | 0.15MG | CAPSULE / ORAL | 1984-09-24 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N018118-001 | LANOXICAPS | 0.2MG | CAPSULE / ORAL | 1982-07-26 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N018118-002 | LANOXICAPS | 0.05MG | CAPSULE / ORAL | 1982-07-26 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N018118-003 | LANOXICAPS | 0.1MG | CAPSULE / ORAL | 1982-07-26 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N018118-004 | LANOXICAPS | 0.15MG | CAPSULE / ORAL | 1984-09-24 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018118-001 | LANOXICAPS | 0.2MG | CAPSULE / ORAL | 1982-07-26 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018118-002 | LANOXICAPS | 0.05MG | CAPSULE / ORAL | 1982-07-26 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018118-003 | LANOXICAPS | 0.1MG | CAPSULE / ORAL | 1982-07-26 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018118-004 | LANOXICAPS | 0.15MG | CAPSULE / ORAL | 1984-09-24 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N018118-001 | LANOXICAPS | 0.2MG | CAPSULE / ORAL | 1982-07-26 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N018118-002 | LANOXICAPS | 0.05MG | CAPSULE / ORAL | 1982-07-26 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N018118-003 | LANOXICAPS | 0.1MG | CAPSULE / ORAL | 1982-07-26 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N018118-004 | LANOXICAPS | 0.15MG | CAPSULE / ORAL | 1984-09-24 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018118-001 | LANOXICAPS | 0.2MG | CAPSULE / ORAL | 1982-07-26 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018118-002 | LANOXICAPS | 0.05MG | CAPSULE / ORAL | 1982-07-26 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018118-003 | LANOXICAPS | 0.1MG | CAPSULE / ORAL | 1982-07-26 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018118-004 | LANOXICAPS | 0.15MG | CAPSULE / ORAL | 1984-09-24 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018118-001 | LANOXICAPS | 0.2MG | CAPSULE / ORAL | 1982-07-26 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018118-002 | LANOXICAPS | 0.05MG | CAPSULE / ORAL | 1982-07-26 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018118-003 | LANOXICAPS | 0.1MG | CAPSULE / ORAL | 1982-07-26 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018118-004 | LANOXICAPS | 0.15MG | CAPSULE / ORAL | 1984-09-24 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018118-001 | LANOXICAPS | 0.2MG | CAPSULE / ORAL | 1982-07-26 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018118-002 | LANOXICAPS | 0.05MG | CAPSULE / ORAL | 1982-07-26 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018118-003 | LANOXICAPS | 0.1MG | CAPSULE / ORAL | 1982-07-26 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018118-004 | LANOXICAPS | 0.15MG | CAPSULE / ORAL | 1984-09-24 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018118-001 | LANOXICAPS | 0.2MG | CAPSULE / ORAL | 1982-07-26 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018118-002 | LANOXICAPS | 0.05MG | CAPSULE / ORAL | 1982-07-26 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018118-003 | LANOXICAPS | 0.1MG | CAPSULE / ORAL | 1982-07-26 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018118-004 | LANOXICAPS | 0.15MG | CAPSULE / ORAL | 1984-09-24 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018118-001 | LANOXICAPS | 0.2MG | CAPSULE / ORAL | 1982-07-26 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018118-002 | LANOXICAPS | 0.05MG | CAPSULE / ORAL | 1982-07-26 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018118-003 | LANOXICAPS | 0.1MG | CAPSULE / ORAL | 1982-07-26 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018118-004 | LANOXICAPS | 0.15MG | CAPSULE / ORAL | 1984-09-24 | 5bbf6a4d5a75… |
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 |
|---|---|---|---|---|---|---|
| Digoxin | DIGOXIN | A-S Medication Solutions | aea39b37-951e-49e8-9756-c763c0e7c7cd | 2023-11-24 | Warnings, Adverse reactions | DIGOXIN |
| Digoxin | DIGOXIN | A-S Medication Solutions | 0a88434e-4a1b-4ade-a51e-38145e22a232 | 2023-08-14 | Warnings, Adverse reactions | DIGOXIN |
| LANOXIN | DIGOXIN | Aphena Pharma Solutions - Tennessee, LLC | f6c7ca21-1c76-4838-8fb9-e1bec6001d8b | 2019-05-08 | Warnings, Adverse reactions | DIGOXIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.