Application 050467
- Type
- NDA
- Sponsor
- PHARMACIA AND UPJOHN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 10MG/VIAL | No | No |
| 002 | DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/VIAL | No | No |
| 003 | DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 20MG/VIAL | No | No |
| 004 | DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 150MG/VIAL | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050467-001 | DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | 10MG/VIAL | INJECTABLE / INJECTION | Approved before 1982 | ||
| N050467-002 | DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | 50MG/VIAL | INJECTABLE / INJECTION | Approved before 1982 | ||
| N050467-003 | DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | 20MG/VIAL | INJECTABLE / INJECTION | 1985-05-20 | ||
| N050467-004 | DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | 150MG/VIAL | INJECTABLE / INJECTION | 1987-07-22 |
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 | N050467-001 | DOXORUBICIN HYDROCHLORIDE | 10MG/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N050467-002 | DOXORUBICIN HYDROCHLORIDE | 50MG/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N050467-003 | DOXORUBICIN HYDROCHLORIDE | 20MG/VIAL | INJECTABLE / INJECTION | 1985-05-20 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N050467-004 | DOXORUBICIN HYDROCHLORIDE | 150MG/VIAL | INJECTABLE / INJECTION | 1987-07-22 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N050467-001 | DOXORUBICIN HYDROCHLORIDE | 10MG/VIAL | INJECTABLE / INJECTION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N050467-002 | DOXORUBICIN HYDROCHLORIDE | 50MG/VIAL | INJECTABLE / INJECTION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N050467-003 | DOXORUBICIN HYDROCHLORIDE | 20MG/VIAL | INJECTABLE / INJECTION | 1985-05-20 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N050467-004 | DOXORUBICIN HYDROCHLORIDE | 150MG/VIAL | INJECTABLE / INJECTION | 1987-07-22 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050467-001 | DOXORUBICIN HYDROCHLORIDE | 10MG/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050467-002 | DOXORUBICIN HYDROCHLORIDE | 50MG/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050467-003 | DOXORUBICIN HYDROCHLORIDE | 20MG/VIAL | INJECTABLE / INJECTION | 1985-05-20 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050467-004 | DOXORUBICIN HYDROCHLORIDE | 150MG/VIAL | INJECTABLE / INJECTION | 1987-07-22 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050467-001 | DOXORUBICIN HYDROCHLORIDE | 10MG/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050467-002 | DOXORUBICIN HYDROCHLORIDE | 50MG/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050467-003 | DOXORUBICIN HYDROCHLORIDE | 20MG/VIAL | INJECTABLE / INJECTION | 1985-05-20 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050467-004 | DOXORUBICIN HYDROCHLORIDE | 150MG/VIAL | INJECTABLE / INJECTION | 1987-07-22 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N050467-001 | DOXORUBICIN HYDROCHLORIDE | 10MG/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N050467-002 | DOXORUBICIN HYDROCHLORIDE | 50MG/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N050467-003 | DOXORUBICIN HYDROCHLORIDE | 20MG/VIAL | INJECTABLE / INJECTION | 1985-05-20 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N050467-004 | DOXORUBICIN HYDROCHLORIDE | 150MG/VIAL | INJECTABLE / INJECTION | 1987-07-22 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050467-001 | DOXORUBICIN HYDROCHLORIDE | 10MG/VIAL | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050467-002 | DOXORUBICIN HYDROCHLORIDE | 50MG/VIAL | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050467-003 | DOXORUBICIN HYDROCHLORIDE | 20MG/VIAL | INJECTABLE / INJECTION | 1985-05-20 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050467-004 | DOXORUBICIN HYDROCHLORIDE | 150MG/VIAL | INJECTABLE / INJECTION | 1987-07-22 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050467-001 | DOXORUBICIN HYDROCHLORIDE | 10MG/VIAL | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050467-002 | DOXORUBICIN HYDROCHLORIDE | 50MG/VIAL | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050467-003 | DOXORUBICIN HYDROCHLORIDE | 20MG/VIAL | INJECTABLE / INJECTION | 1985-05-20 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050467-004 | DOXORUBICIN HYDROCHLORIDE | 150MG/VIAL | INJECTABLE / INJECTION | 1987-07-22 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050467-001 | DOXORUBICIN HYDROCHLORIDE | 10MG/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050467-002 | DOXORUBICIN HYDROCHLORIDE | 50MG/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050467-003 | DOXORUBICIN HYDROCHLORIDE | 20MG/VIAL | INJECTABLE / INJECTION | 1985-05-20 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050467-004 | DOXORUBICIN HYDROCHLORIDE | 150MG/VIAL | INJECTABLE / INJECTION | 1987-07-22 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050467-001 | DOXORUBICIN HYDROCHLORIDE | 10MG/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050467-002 | DOXORUBICIN HYDROCHLORIDE | 50MG/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050467-003 | DOXORUBICIN HYDROCHLORIDE | 20MG/VIAL | INJECTABLE / INJECTION | 1985-05-20 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050467-004 | DOXORUBICIN HYDROCHLORIDE | 150MG/VIAL | INJECTABLE / INJECTION | 1987-07-22 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050467-001 | DOXORUBICIN HYDROCHLORIDE | 10MG/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050467-002 | DOXORUBICIN HYDROCHLORIDE | 50MG/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050467-003 | DOXORUBICIN HYDROCHLORIDE | 20MG/VIAL | INJECTABLE / INJECTION | 1985-05-20 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050467-004 | DOXORUBICIN HYDROCHLORIDE | 150MG/VIAL | INJECTABLE / INJECTION | 1987-07-22 | 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 |
|---|---|---|---|---|---|---|
| Doxorubicin Hydrochloride | DOXORUBICIN HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | f62aa88d-1e25-4049-87ec-99d42edd1d31 | 2024-04-26 | Boxed warning, Warnings, Adverse reactions | Doxorubicin Hydrochloride DOXORUBICIN HYDROCHLORIDE |
| Doxorubicin Hydrochloride | DOXORUBICIN HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 36924f82-6c05-4989-9f41-a398c0ad48e6 | 2024-04-26 | Boxed warning, Warnings, Adverse reactions | Doxorubicin Hydrochloride DOXORUBICIN HYDROCHLORIDE |
| Doxorubicin Hydrochloride | DOXORUBICIN HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 971de64b-ff09-4370-afd9-6eb1093ad27d | 2024-01-16 | Boxed warning, Warnings, Adverse reactions | Doxorubicin Hydrochloride DOXORUBICIN HYDROCHLORIDE |
| doxorubicin hydrochloride, Liposomal | DOXORUBICIN HYDROCHLORIDE | Baxter Healthcare Corporation | b24afa8c-636b-4ace-99d5-51f445ad3123 | 2023-12-19 | DOXORUBICIN HYDROCHLORIDE | |
| DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | Zydus Lifesciences Limited | bad467d4-7e27-4eda-b4d3-854460f0adab | 2022-11-01 | DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE | |
| Doxorubicin Hydrochloride | DOXORUBICIN HYDROCHLORIDE | Mylan Institutional LLC | 5f71f79a-4f14-472d-b982-e28c3ce8f972 | 2022-07-01 | Boxed warning, Warnings, Adverse reactions | Doxorubicin Hydrochloride DOXORUBICIN HYDROCHLORIDE |
| DOXIL | DOXORUBICIN HYDROCHLORIDE | Baxter Healthcare Company | 1c153e9e-4cf2-4ac7-9cf9-16f9b48d7dce | 2022-05-31 | Boxed warning, Warnings, Adverse reactions | DOXORUBICIN HYDROCHLORIDE |
| DOXOrubicin Hydrochloride | DOXORUBICIN HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | 6bcde92b-e584-4919-866a-68847ea201ba | 2022-01-17 | Boxed warning, Warnings, Adverse reactions | DOXOrubicin Hydrochloride DOXORUBICIN HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 65071 | SUPPL | 2020-10-29 |
| 64451 | SUPPL | 2020-08-31 |
| 61440 | SUPPL | 2019-12-26 |
| 61389 | SUPPL | 2019-12-23 |
| 59670 | SUPPL | 2019-08-12 |
| 59664 | SUPPL | 2019-08-12 |
| 7762 | SUPPL | 2013-11-06 |
| 17840 | SUPPL | 2013-11-01 |
| 30041 | SUPPL | 2011-09-29 |
| 38948 | SUPPL | 2011-09-26 |
| 7761 | SUPPL | 2010-08-09 |
| 38947 | SUPPL | 2010-07-30 |
| 30040 | SUPPL | 2003-05-30 |
| 7760 | SUPPL | 2003-05-30 |
| 17839 | SUPPL | 2003-05-29 |
| 38946 | SUPPL | 2003-05-13 |
| 38945 | SUPPL | 2002-09-25 |
| 30039 | SUPPL | 2002-09-25 |
| 30038 | SUPPL | 2002-09-25 |
| 17838 | SUPPL | 2002-09-25 |