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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A063165-001 | ADRIAMYCIN PFS | 2MG/ML | INJECTABLE / INJECTION | 1991-01-30 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A063165-002 | ADRIAMYCIN PFS | 200MG/100ML | INJECTABLE / INJECTION | 1991-01-30 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A063165-001 | ADRIAMYCIN PFS | 2MG/ML | INJECTABLE / INJECTION | 1991-01-30 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A063165-002 | ADRIAMYCIN PFS | 200MG/100ML | INJECTABLE / INJECTION | 1991-01-30 | 782e0a99824c… |
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 | BluePoint Laboratories | 55889588-c5f1-d9bc-e063-6294a90a5791 | 2026-07-09 | Boxed warning, Warnings, Adverse reactions | DOXORUBICIN HYDROCHLORIDE |
| Doxorubicin Hydrochloride | DOXORUBICIN HYDROCHLORIDE | BluePoint Laboratories | f6508535-e7a7-4e50-8d0c-43deda8d0d08 | 2026-05-21 | Boxed warning, Warnings, Adverse reactions | DOXORUBICIN HYDROCHLORIDE |
| Doxorubicin Hydrochloride | DOXORUBICIN HYDROCHLORIDE | Pfizer Laboratories Div Pfizer Inc | 1fd148fb-0fbc-4b6f-b790-23546fb46a71 | 2026-05-05 | Boxed warning, Warnings, Adverse reactions | DOXORUBICIN HYDROCHLORIDE |
| Doxorubicin Hydrochloride | DOXORUBICIN HYDROCHLORIDE | Pfizer Laboratories Div Pfizer Inc | 00634b2b-4e48-4178-8877-28582af894ad | 2026-04-30 | Boxed warning, Warnings, Adverse reactions | DOXORUBICIN HYDROCHLORIDE |
| Doxorubicin Hydrochloride | DOXORUBICIN HYDROCHLORIDE | NorthStar RxLLC | ddf55319-bf62-4ec7-8be2-ef97188837c4 | 2026-04-10 | Boxed warning, Warnings, Adverse reactions | DOXORUBICIN HYDROCHLORIDE |
| Doxorubicin Hydrochloride | DOXORUBICIN HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | fbc48fa5-0bfb-4957-b13c-a56bb7a13b56 | 2026-04-06 | Boxed warning, Warnings, Adverse reactions | DOXORUBICIN HYDROCHLORIDE |
| DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | BluePoint Laboratories | ada390ce-50ea-4de5-be58-5b03caf33c23 | 2026-03-27 | Boxed warning, Warnings, Adverse reactions | DOXORUBICIN HYDROCHLORIDE |
| DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | Zydus Pharmaceuticals USA Inc. | 15a84bd6-b565-4722-bb92-e4c919620a90 | 2026-03-17 | Boxed warning, Warnings, Adverse reactions | DOXORUBICIN HYDROCHLORIDE |
| DOXIL | DOXORUBICIN HYDROCHLORIDE | Baxter Healthcare Corporation | 917eddf9-1d3f-4abe-8c81-d33b066e5bae | 2026-03-10 | Boxed warning, Warnings, Adverse reactions | DOXORUBICIN HYDROCHLORIDE |
| Doxorubicin Hydrochloride Liposome | DOXORUBICIN HYDROCHLORIDE | Sagent Pharmaceuticals | c8eb4784-36e0-483f-9e5d-af0552e49bb5 | 2026-02-24 | Boxed warning, Warnings, Adverse reactions | DOXORUBICIN HYDROCHLORIDE |
| DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | 0f8eb9a1-74d0-47fd-94b8-a65b29006521 | 2025-11-30 | Boxed warning, Warnings, Adverse reactions | DOXORUBICIN HYDROCHLORIDE |
| doxorubicin hydrochloride | DOXORUBICIN HYDROCHLORIDE | Dr. Reddy's Laboratories Inc. | 0885dddf-727e-4692-92dd-a26c69cc278d | 2025-11-29 | Boxed warning, Warnings, Adverse reactions | DOXORUBICIN HYDROCHLORIDE |
| doxorubicin hydrochloride | DOXORUBICIN HYDROCHLORIDE | Alembic Pharmaceuticals Inc. | c9cb8a8d-944f-4fe1-bfba-c55904a79fda | 2025-07-01 | Boxed warning, Warnings, Adverse reactions | DOXORUBICIN HYDROCHLORIDE |
| doxorubicin hydrochloride | DOXORUBICIN HYDROCHLORIDE | Sagent Pharmaceuticals | ae80bd3a-b99a-4e01-a444-b9d05687f00e | 2025-07-01 | Boxed warning, Warnings, Adverse reactions | DOXORUBICIN HYDROCHLORIDE |
| doxorubicin hydrochloride | DOXORUBICIN HYDROCHLORIDE | Alembic Pharmaceuticals Limited | f8e001f5-441c-47cd-86f6-5d5e3de16bc0 | 2025-07-01 | Boxed warning, Warnings, Adverse reactions | DOXORUBICIN HYDROCHLORIDE |
| Doxorubicin Hydrochloride | DOXORUBICIN HYDROCHLORIDE | Pfizer Laboratories Div Pfizer Inc | d31d7f58-66d0-4826-b6b5-5914c031965f | 2025-03-31 | Boxed warning, Warnings, Adverse reactions | DOXORUBICIN HYDROCHLORIDE |
| DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | BluePoint Laboratories | b8b66e93-0813-4876-b291-8d7c36a99807 | 2024-12-11 | Boxed warning, Warnings, Adverse reactions | DOXORUBICIN HYDROCHLORIDE |
| Doxorubicin Hydrochloride | DOXORUBICIN HYDROCHLORIDE | Fresenius Kabi USA, LLC | e0349f98-42fa-4003-b6d8-a1db1401b0ef | 2024-10-14 | Boxed warning, Warnings, Adverse reactions | DOXORUBICIN HYDROCHLORIDE |
| Doxorubicin Hydrochloride | DOXORUBICIN HYDROCHLORIDE | Gland Pharma Limited | 74b14803-afc8-4a2e-ba92-43f1a72025eb | 2024-09-24 | Boxed warning, Warnings, Adverse reactions | DOXORUBICIN HYDROCHLORIDE |
| Doxorubicin hydrochloride | DOXORUBICIN HYDROCHLORIDE | Actavis Pharma, Inc. | 33ddfdb1-b4bc-464d-a186-49c4b156279f | 2024-07-01 | Boxed warning, Warnings, Adverse reactions | DOXORUBICIN HYDROCHLORIDE |