Application 050718
- Type
- NDA
- Sponsor
- BAXTER HLTHCARE CORP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DOXIL (LIPOSOMAL) | DOXORUBICIN HYDROCHLORIDE | INJECTABLE, LIPOSOMAL;INJECTION | 20MG/10ML (2MG/ML) | Yes | No |
| 002 | DOXIL (LIPOSOMAL) | DOXORUBICIN HYDROCHLORIDE | INJECTABLE, LIPOSOMAL;INJECTION | 50MG/25ML (2MG/ML) | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050718-001 | DOXIL (LIPOSOMAL) | DOXORUBICIN HYDROCHLORIDE | 20MG/10ML (2MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AB | RLD | 1995-11-17 |
| N050718-002 | DOXIL (LIPOSOMAL) | DOXORUBICIN HYDROCHLORIDE | 50MG/25ML (2MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AB | RLD | 2000-06-13 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N050718-001 | AB |
| N050718-002 | AB |
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 | N050718-001 | DOXIL (LIPOSOMAL) | 20MG/10ML (2MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AB | RLD | 1995-11-17 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N050718-002 | DOXIL (LIPOSOMAL) | 50MG/25ML (2MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AB | RLD | 2000-06-13 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050718-001 | DOXIL (LIPOSOMAL) | 20MG/10ML (2MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AB | RLD | 1995-11-17 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050718-002 | DOXIL (LIPOSOMAL) | 50MG/25ML (2MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AB | RLD | 2000-06-13 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N050718-001 | DOXIL (LIPOSOMAL) | 20MG/10ML (2MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AB | RLD | 1995-11-17 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N050718-002 | DOXIL (LIPOSOMAL) | 50MG/25ML (2MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AB | RLD | 2000-06-13 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050718-001 | DOXIL (LIPOSOMAL) | 20MG/10ML (2MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AB | RLD | 1995-11-17 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050718-002 | DOXIL (LIPOSOMAL) | 50MG/25ML (2MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AB | RLD | 2000-06-13 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050718-001 | DOXIL (LIPOSOMAL) | 20MG/10ML (2MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AB | RLD | 1995-11-17 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050718-002 | DOXIL (LIPOSOMAL) | 50MG/25ML (2MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AB | RLD | 2000-06-13 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050718-001 | DOXIL (LIPOSOMAL) | 20MG/10ML (2MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AB | RLD | 1995-11-17 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050718-002 | DOXIL (LIPOSOMAL) | 50MG/25ML (2MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AB | RLD | 2000-06-13 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050718-001 | DOXIL (LIPOSOMAL) | 20MG/10ML (2MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AB | RLD | 1995-11-17 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050718-002 | DOXIL (LIPOSOMAL) | 50MG/25ML (2MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AB | RLD | 2000-06-13 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050718-001 | DOXIL (LIPOSOMAL) | 20MG/10ML (2MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AB | RLD | 1995-11-17 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050718-002 | DOXIL (LIPOSOMAL) | 50MG/25ML (2MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AB | RLD | 2000-06-13 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050718-001 | DOXIL (LIPOSOMAL) | 20MG/10ML (2MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AB | RLD | 1995-11-17 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050718-002 | DOXIL (LIPOSOMAL) | 50MG/25ML (2MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AB | RLD | 2000-06-13 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N050718-001 | DOXIL (LIPOSOMAL) | 20MG/10ML (2MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AB | RLD | 1995-11-17 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N050718-002 | DOXIL (LIPOSOMAL) | 50MG/25ML (2MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AB | RLD | 2000-06-13 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050718-001 | DOXIL (LIPOSOMAL) | 20MG/10ML (2MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AB | RLD | 1995-11-17 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050718-002 | DOXIL (LIPOSOMAL) | 50MG/25ML (2MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AB | RLD | 2000-06-13 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050718-001 | DOXIL (LIPOSOMAL) | 20MG/10ML (2MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AB | RLD | 1995-11-17 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050718-002 | DOXIL (LIPOSOMAL) | 50MG/25ML (2MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AB | RLD | 2000-06-13 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050718-001 | DOXIL (LIPOSOMAL) | 20MG/10ML (2MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AB | RLD | 1995-11-17 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050718-002 | DOXIL (LIPOSOMAL) | 50MG/25ML (2MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AB | RLD | 2000-06-13 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N050718-001 | DOXIL (LIPOSOMAL) | 20MG/10ML (2MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AB | RLD | 1995-11-17 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N050718-002 | DOXIL (LIPOSOMAL) | 50MG/25ML (2MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AB | RLD | 2000-06-13 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050718-001 | DOXIL (LIPOSOMAL) | 20MG/10ML (2MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AB | RLD | 1995-11-17 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050718-002 | DOXIL (LIPOSOMAL) | 50MG/25ML (2MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AB | RLD | 2000-06-13 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N050718-001 | DOXIL (LIPOSOMAL) | 20MG/10ML (2MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AB | RLD | 1995-11-17 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N050718-002 | DOXIL (LIPOSOMAL) | 50MG/25ML (2MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AB | RLD | 2000-06-13 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N050718-001 | DOXIL (LIPOSOMAL) | 20MG/10ML (2MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AB | RLD | 1995-11-17 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N050718-002 | DOXIL (LIPOSOMAL) | 50MG/25ML (2MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AB | RLD | 2000-06-13 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N050718-001 | DOXIL (LIPOSOMAL) | 20MG/10ML (2MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AB | RLD | 1995-11-17 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N050718-002 | DOXIL (LIPOSOMAL) | 50MG/25ML (2MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AB | RLD | 2000-06-13 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N050718-001 | DOXIL (LIPOSOMAL) | 20MG/10ML (2MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AB | RLD | 1995-11-17 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N050718-002 | DOXIL (LIPOSOMAL) | 50MG/25ML (2MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AB | RLD | 2000-06-13 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N050718-001 | DOXIL (LIPOSOMAL) | 20MG/10ML (2MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AB | RLD | 1995-11-17 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N050718-002 | DOXIL (LIPOSOMAL) | 50MG/25ML (2MG/ML) | INJECTABLE, LIPOSOMAL / INJECTION | AB | RLD | 2000-06-13 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N050718-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N050718-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050718-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050718-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N050718-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N050718-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050718-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050718-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050718-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050718-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050718-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050718-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050718-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050718-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050718-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050718-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050718-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050718-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N050718-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N050718-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050718-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050718-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050718-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050718-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050718-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050718-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N050718-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N050718-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050718-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050718-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N050718-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N050718-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N050718-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N050718-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N050718-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N050718-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N050718-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N050718-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N050718-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N050718-002 | AB | 1 | 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 |
|---|---|---|---|---|---|---|
| DOXIL | DOXORUBICIN HYDROCHLORIDE | Baxter Healthcare Corporation | 917eddf9-1d3f-4abe-8c81-d33b066e5bae | 2026-03-10 | Boxed warning, Warnings, Adverse reactions | 050718 NDA050718 |
| DOXIL | DOXORUBICIN HYDROCHLORIDE | Baxter Healthcare Company | 1c153e9e-4cf2-4ac7-9cf9-16f9b48d7dce | 2022-05-31 | Boxed warning, Warnings, Adverse reactions | 050718 NDA050718 0338-0063 0338-0067 |
| Doxorubicin Hydrochloride Liposome | DOXORUBICIN HYDROCHLORIDE LIPOSOME | Baxter Healthcare Company | cf25a018-e795-49e4-8533-a581f8366dd9 | 2022-05-31 | Boxed warning, Warnings, Adverse reactions | 050718 NDA050718 0338-0080 0338-0086 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0338-0063 | DOXIL | doxorubicin hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 0338-0063 | DOXIL | doxorubicin hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 0338-0063 | DOXIL | doxorubicin hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 0338-0063 | DOXIL | doxorubicin hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 0338-0063 | DOXIL | doxorubicin hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 0338-0063 | DOXIL | doxorubicin hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 0338-0063 | DOXIL | doxorubicin hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 0338-0067 | DOXIL | doxorubicin hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 0338-0067 | DOXIL | doxorubicin hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 0338-0067 | DOXIL | doxorubicin hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 0338-0067 | DOXIL | doxorubicin hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 0338-0067 | DOXIL | doxorubicin hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 0338-0067 | DOXIL | doxorubicin hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 0338-0067 | DOXIL | doxorubicin hydrochloride | Baxter Healthcare Corporation | NDA | Current |
| 0338-0080 | Doxorubicin Hydrochloride Liposome | Doxorubicin Hydrochloride Liposome | Baxter Healthcare Corporation | NDA | Current |
| 0338-0080 | Doxorubicin Hydrochloride Liposome | Doxorubicin Hydrochloride Liposome | Baxter Healthcare Corporation | NDA | Current |
| 0338-0080 | Doxorubicin Hydrochloride Liposome | Doxorubicin Hydrochloride Liposome | Baxter Healthcare Corporation | NDA | Current |
| 0338-0080 | Doxorubicin Hydrochloride Liposome | Doxorubicin Hydrochloride Liposome | Baxter Healthcare Corporation | NDA | Current |
| 0338-0080 | Doxorubicin Hydrochloride Liposome | Doxorubicin Hydrochloride Liposome | Baxter Healthcare Corporation | NDA | Current |
| 0338-0080 | Doxorubicin Hydrochloride Liposome | Doxorubicin Hydrochloride Liposome | Baxter Healthcare Corporation | NDA | Current |
| 0338-0086 | Doxorubicin Hydrochloride Liposome | Doxorubicin Hydrochloride Liposome | Baxter Healthcare Corporation | NDA | Current |
| 0338-0086 | Doxorubicin Hydrochloride Liposome | Doxorubicin Hydrochloride Liposome | Baxter Healthcare Corporation | NDA | Current |
| 0338-0086 | Doxorubicin Hydrochloride Liposome | Doxorubicin Hydrochloride Liposome | Baxter Healthcare Corporation | NDA | Current |
| 0338-0086 | Doxorubicin Hydrochloride Liposome | Doxorubicin Hydrochloride Liposome | Baxter Healthcare Corporation | NDA | Current |
| 0338-0086 | Doxorubicin Hydrochloride Liposome | Doxorubicin Hydrochloride Liposome | Baxter Healthcare Corporation | NDA | Current |
| 0338-0086 | Doxorubicin Hydrochloride Liposome | Doxorubicin Hydrochloride Liposome | Baxter Healthcare Corporation | NDA | Current |
| 59676-960 | DOXIL | doxorubicin hydrochloride | Janssen Products, LP | NDA | Current |
| 59676-960 | DOXIL | doxorubicin hydrochloride | Janssen Products, LP | NDA | Current |
| 59676-966 | Doxorubicin Hydrochloride liposome | doxorubicin hydrochloride | Janssen Products, LP | NDA | Current |
| 59676-966 | Doxorubicin Hydrochloride liposome | doxorubicin hydrochloride | Janssen Products, LP | NDA | Current |
| 59676-966 | Doxorubicin Hydrochloride liposome | doxorubicin hydrochloride | Janssen Products, LP | NDA | Current |
| 59676-966 | Doxorubicin Hydrochloride liposome | doxorubicin hydrochloride | Janssen Products, LP | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85359 | SUPPL | 2026-03-12 |
| 85333 | SUPPL | 2026-03-12 |
| 71041 | SUPPL | 2022-05-11 |
| 71027 | SUPPL | 2022-05-09 |
| 67007 | SUPPL | 2021-04-07 |
| 59694 | SUPPL | 2019-08-13 |
| 59692 | SUPPL | 2019-08-13 |
| 50611 | SUPPL | 2017-12-06 |
| 49020 | SUPPL | 2017-07-20 |
| 48428 | SUPPL | 2017-05-17 |
| 8095 | SUPPL | 2015-12-29 |
| 18106 | SUPPL | 2015-04-17 |
| 8094 | SUPPL | 2015-04-17 |
| 39176 | SUPPL | 2015-01-29 |
| 39175 | SUPPL | 2013-09-09 |
| 30356 | SUPPL | 2013-09-04 |
| 30355 | SUPPL | 2012-09-24 |
| 18105 | SUPPL | 2012-09-20 |
| 42688 | SUPPL | 2011-10-10 |
| 44786 | SUPPL | 2008-07-17 |
| 39174 | SUPPL | 2008-06-19 |
| 30354 | SUPPL | 2008-06-13 |
| 39172 | SUPPL | 2007-05-29 |
| 30353 | SUPPL | 2007-05-29 |
| 8093 | SUPPL | 2007-05-29 |
| 39173 | SUPPL | 2007-05-18 |
| 30352 | SUPPL | 2005-02-03 |
| 18104 | SUPPL | 2005-02-03 |
| 18103 | SUPPL | 2004-11-01 |
| 30351 | SUPPL | 2004-10-29 |
| 8092 | SUPPL | 2004-06-02 |
| 39171 | SUPPL | 1999-06-28 |
| 30350 | SUPPL | 1999-06-28 |