Application 050661
- Type
- NDA
- Sponsor
- PHARMACIA AND UPJOHN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IDAMYCIN | IDARUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 10MG/VIAL | No | No |
| 002 | IDAMYCIN | IDARUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 5MG/VIAL | No | No |
| 003 | IDAMYCIN | IDARUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 20MG/VIAL | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050661-001 | IDAMYCIN | IDARUBICIN HYDROCHLORIDE | 10MG/VIAL | POWDER / INTRAVENOUS | 1990-09-27 | ||
| N050661-002 | IDAMYCIN | IDARUBICIN HYDROCHLORIDE | 5MG/VIAL | POWDER / INTRAVENOUS | 1990-09-27 | ||
| N050661-003 | IDAMYCIN | IDARUBICIN HYDROCHLORIDE | 20MG/VIAL | POWDER / INTRAVENOUS | 1995-04-25 |
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 | N050661-001 | IDAMYCIN | 10MG/VIAL | POWDER / INTRAVENOUS | 1990-09-27 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N050661-002 | IDAMYCIN | 5MG/VIAL | POWDER / INTRAVENOUS | 1990-09-27 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N050661-003 | IDAMYCIN | 20MG/VIAL | POWDER / INTRAVENOUS | 1995-04-25 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N050661-001 | IDAMYCIN | 10MG/VIAL | POWDER / INTRAVENOUS | 1990-09-27 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N050661-002 | IDAMYCIN | 5MG/VIAL | POWDER / INTRAVENOUS | 1990-09-27 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N050661-003 | IDAMYCIN | 20MG/VIAL | POWDER / INTRAVENOUS | 1995-04-25 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050661-001 | IDAMYCIN | 10MG/VIAL | POWDER / INTRAVENOUS | 1990-09-27 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050661-002 | IDAMYCIN | 5MG/VIAL | POWDER / INTRAVENOUS | 1990-09-27 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050661-003 | IDAMYCIN | 20MG/VIAL | POWDER / INTRAVENOUS | 1995-04-25 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050661-001 | IDAMYCIN | 10MG/VIAL | POWDER / INTRAVENOUS | 1990-09-27 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050661-002 | IDAMYCIN | 5MG/VIAL | POWDER / INTRAVENOUS | 1990-09-27 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050661-003 | IDAMYCIN | 20MG/VIAL | POWDER / INTRAVENOUS | 1995-04-25 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N050661-001 | IDAMYCIN | 10MG/VIAL | INJECTABLE / INJECTION | 1990-09-27 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N050661-002 | IDAMYCIN | 5MG/VIAL | INJECTABLE / INJECTION | 1990-09-27 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N050661-003 | IDAMYCIN | 20MG/VIAL | INJECTABLE / INJECTION | 1995-04-25 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050661-001 | IDAMYCIN | 10MG/VIAL | INJECTABLE / INJECTION | 1990-09-27 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050661-002 | IDAMYCIN | 5MG/VIAL | INJECTABLE / INJECTION | 1990-09-27 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050661-003 | IDAMYCIN | 20MG/VIAL | INJECTABLE / INJECTION | 1995-04-25 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050661-001 | IDAMYCIN | 10MG/VIAL | INJECTABLE / INJECTION | 1990-09-27 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050661-002 | IDAMYCIN | 5MG/VIAL | INJECTABLE / INJECTION | 1990-09-27 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050661-003 | IDAMYCIN | 20MG/VIAL | INJECTABLE / INJECTION | 1995-04-25 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050661-001 | IDAMYCIN | 10MG/VIAL | INJECTABLE / INJECTION | 1990-09-27 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050661-002 | IDAMYCIN | 5MG/VIAL | INJECTABLE / INJECTION | 1990-09-27 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050661-003 | IDAMYCIN | 20MG/VIAL | INJECTABLE / INJECTION | 1995-04-25 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050661-001 | IDAMYCIN | 10MG/VIAL | INJECTABLE / INJECTION | 1990-09-27 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050661-002 | IDAMYCIN | 5MG/VIAL | INJECTABLE / INJECTION | 1990-09-27 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050661-003 | IDAMYCIN | 20MG/VIAL | INJECTABLE / INJECTION | 1995-04-25 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050661-001 | IDAMYCIN | 10MG/VIAL | INJECTABLE / INJECTION | 1990-09-27 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050661-002 | IDAMYCIN | 5MG/VIAL | INJECTABLE / INJECTION | 1990-09-27 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050661-003 | IDAMYCIN | 20MG/VIAL | INJECTABLE / INJECTION | 1995-04-25 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050661-001 | IDAMYCIN | 10MG/VIAL | INJECTABLE / INJECTION | 1990-09-27 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050661-002 | IDAMYCIN | 5MG/VIAL | INJECTABLE / INJECTION | 1990-09-27 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050661-003 | IDAMYCIN | 20MG/VIAL | INJECTABLE / INJECTION | 1995-04-25 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N050661-001 | IDAMYCIN | 10MG/VIAL | INJECTABLE / INJECTION | 1990-09-27 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N050661-002 | IDAMYCIN | 5MG/VIAL | INJECTABLE / INJECTION | 1990-09-27 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N050661-003 | IDAMYCIN | 20MG/VIAL | INJECTABLE / INJECTION | 1995-04-25 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050661-001 | IDAMYCIN | 10MG/VIAL | INJECTABLE / INJECTION | 1990-09-27 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050661-002 | IDAMYCIN | 5MG/VIAL | INJECTABLE / INJECTION | 1990-09-27 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050661-003 | IDAMYCIN | 20MG/VIAL | INJECTABLE / INJECTION | 1995-04-25 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050661-001 | IDAMYCIN | 10MG/VIAL | INJECTABLE / INJECTION | 1990-09-27 | 301d65b070ca… |
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 |
|---|---|---|---|---|---|---|
| Idamycin PFS | IDARUBICIN HYDROCHLORIDE | Pfizer Laboratories Div Pfizer Inc | 0a5a6d93-cc1e-4d7f-8da1-446c134503b3 | 2026-04-15 | Boxed warning, Warnings, Adverse reactions | IDARUBICIN HYDROCHLORIDE |
| Idarubicin Hydrochloride | IDARUBICIN HYDROCHLORIDE | Meitheal Pharmaceuticals Inc. | d31254be-6bd2-4ac1-acab-bc00e2209d28 | 2025-05-09 | Boxed warning, Warnings, Adverse reactions | IDARUBICIN HYDROCHLORIDE |
| Idarubicin Hydrochloride | IDARUBICIN HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 7c20b574-285b-49eb-a98e-6752e4bb481d | 2025-01-07 | Boxed warning, Warnings, Adverse reactions | IDARUBICIN HYDROCHLORIDE |
| Idarubicin Hydrochloride | IDARUBICIN HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | b9b337d5-50f7-4ea9-9df4-72c86e4c0b91 | 2023-04-19 | Boxed warning, Warnings, Adverse reactions | IDARUBICIN HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.