Application 063165
- Type
- ANDA
- Sponsor
- PHARMACIA AND UPJOHN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ADRIAMYCIN PFS | DOXORUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 2MG/ML | No | No |
| 002 | ADRIAMYCIN PFS | DOXORUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 200MG/100ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A063165-001 | ADRIAMYCIN PFS | DOXORUBICIN HYDROCHLORIDE | 2MG/ML | INJECTABLE / INJECTION | 1991-01-30 | ||
| A063165-002 | ADRIAMYCIN PFS | DOXORUBICIN HYDROCHLORIDE | 200MG/100ML | INJECTABLE / INJECTION | 1991-01-30 |
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 | A063165-001 | ADRIAMYCIN PFS | 2MG/ML | INJECTABLE / INJECTION | 1991-01-30 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A063165-002 | ADRIAMYCIN PFS | 200MG/100ML | INJECTABLE / INJECTION | 1991-01-30 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A063165-001 | ADRIAMYCIN PFS | 2MG/ML | INJECTABLE / INJECTION | 1991-01-30 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A063165-002 | ADRIAMYCIN PFS | 200MG/100ML | INJECTABLE / INJECTION | 1991-01-30 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A063165-001 | ADRIAMYCIN PFS | 2MG/ML | INJECTABLE / INJECTION | 1991-01-30 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A063165-002 | ADRIAMYCIN PFS | 200MG/100ML | INJECTABLE / INJECTION | 1991-01-30 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A063165-001 | ADRIAMYCIN PFS | 2MG/ML | INJECTABLE / INJECTION | 1991-01-30 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A063165-002 | ADRIAMYCIN PFS | 200MG/100ML | INJECTABLE / INJECTION | 1991-01-30 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A063165-001 | ADRIAMYCIN PFS | 2MG/ML | INJECTABLE / INJECTION | 1991-01-30 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A063165-002 | ADRIAMYCIN PFS | 200MG/100ML | INJECTABLE / INJECTION | 1991-01-30 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A063165-001 | ADRIAMYCIN PFS | 2MG/ML | INJECTABLE / INJECTION | 1991-01-30 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A063165-002 | ADRIAMYCIN PFS | 200MG/100ML | INJECTABLE / INJECTION | 1991-01-30 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A063165-001 | ADRIAMYCIN PFS | 2MG/ML | INJECTABLE / INJECTION | 1991-01-30 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A063165-002 | ADRIAMYCIN PFS | 200MG/100ML | INJECTABLE / INJECTION | 1991-01-30 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A063165-001 | ADRIAMYCIN PFS | 2MG/ML | INJECTABLE / INJECTION | 1991-01-30 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A063165-002 | ADRIAMYCIN PFS | 200MG/100ML | INJECTABLE / INJECTION | 1991-01-30 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A063165-001 | ADRIAMYCIN PFS | 2MG/ML | INJECTABLE / INJECTION | 1991-01-30 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A063165-002 | ADRIAMYCIN PFS | 200MG/100ML | INJECTABLE / INJECTION | 1991-01-30 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A063165-001 | ADRIAMYCIN PFS | 2MG/ML | INJECTABLE / INJECTION | 1991-01-30 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A063165-002 | ADRIAMYCIN PFS | 200MG/100ML | INJECTABLE / INJECTION | 1991-01-30 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A063165-001 | ADRIAMYCIN PFS | 2MG/ML | INJECTABLE / INJECTION | 1991-01-30 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A063165-002 | ADRIAMYCIN PFS | 200MG/100ML | INJECTABLE / INJECTION | 1991-01-30 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A063165-001 | ADRIAMYCIN PFS | 2MG/ML | INJECTABLE / INJECTION | 1991-01-30 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A063165-002 | ADRIAMYCIN PFS | 200MG/100ML | INJECTABLE / INJECTION | 1991-01-30 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A063165-001 | ADRIAMYCIN PFS | 2MG/ML | INJECTABLE / INJECTION | 1991-01-30 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A063165-002 | ADRIAMYCIN PFS | 200MG/100ML | INJECTABLE / INJECTION | 1991-01-30 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A063165-001 | ADRIAMYCIN PFS | 2MG/ML | INJECTABLE / INJECTION | 1991-01-30 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A063165-002 | ADRIAMYCIN PFS | 200MG/100ML | INJECTABLE / INJECTION | 1991-01-30 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A063165-001 | ADRIAMYCIN PFS | 2MG/ML | INJECTABLE / INJECTION | 1991-01-30 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A063165-002 | ADRIAMYCIN PFS | 200MG/100ML | INJECTABLE / INJECTION | 1991-01-30 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A063165-001 | ADRIAMYCIN PFS | 2MG/ML | INJECTABLE / INJECTION | 1991-01-30 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A063165-002 | ADRIAMYCIN PFS | 200MG/100ML | INJECTABLE / INJECTION | 1991-01-30 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A063165-001 | ADRIAMYCIN PFS | 2MG/ML | INJECTABLE / INJECTION | 1991-01-30 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A063165-002 | ADRIAMYCIN PFS | 200MG/100ML | INJECTABLE / INJECTION | 1991-01-30 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A063165-001 | ADRIAMYCIN PFS | 2MG/ML | INJECTABLE / INJECTION | 1991-01-30 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A063165-002 | ADRIAMYCIN PFS | 200MG/100ML | INJECTABLE / INJECTION | 1991-01-30 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A063165-001 | ADRIAMYCIN PFS | 2MG/ML | INJECTABLE / INJECTION | 1991-01-30 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A063165-002 | ADRIAMYCIN PFS | 200MG/100ML | INJECTABLE / INJECTION | 1991-01-30 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A063165-001 | ADRIAMYCIN PFS | 2MG/ML | INJECTABLE / INJECTION | 1991-01-30 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A063165-002 | ADRIAMYCIN PFS | 200MG/100ML | INJECTABLE / INJECTION | 1991-01-30 | 74a2ff9319b5… |
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. | 36924f82-6c05-4989-9f41-a398c0ad48e6 | 2024-04-26 | Boxed warning, Warnings, Adverse reactions | 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, 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 | BluePoint Laboratories | f1a12eb5-5bdc-45f4-843e-0c971535b184 | 2022-09-28 | Boxed warning, Warnings, Adverse reactions | DOXORUBICIN HYDROCHLORIDE |
| Doxorubicin Hydrochloride | DOXORUBICIN HYDROCHLORIDE | Mylan Institutional LLC | 5f71f79a-4f14-472d-b982-e28c3ce8f972 | 2022-07-01 | Boxed warning, Warnings, Adverse reactions | 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 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.