Application 064212
- Type
- ANDA
- Sponsor
- TEVA PARENTERAL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DAUNORUBICIN HYDROCHLORIDE | DAUNORUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 20MG BASE/VIAL | No | No |
| 002 | DAUNORUBICIN HYDROCHLORIDE | DAUNORUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 50MG BASE/VIAL | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A064212-001 | DAUNORUBICIN HYDROCHLORIDE | DAUNORUBICIN HYDROCHLORIDE | EQ 20MG BASE/VIAL | INJECTABLE / INJECTION | 1998-06-23 | ||
| A064212-002 | DAUNORUBICIN HYDROCHLORIDE | DAUNORUBICIN HYDROCHLORIDE | EQ 50MG BASE/VIAL | INJECTABLE / INJECTION | 1999-05-03 |
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 | A064212-001 | DAUNORUBICIN HYDROCHLORIDE | EQ 20MG BASE/VIAL | INJECTABLE / INJECTION | 1998-06-23 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A064212-002 | DAUNORUBICIN HYDROCHLORIDE | EQ 50MG BASE/VIAL | INJECTABLE / INJECTION | 1999-05-03 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A064212-001 | DAUNORUBICIN HYDROCHLORIDE | EQ 20MG BASE/VIAL | INJECTABLE / INJECTION | 1998-06-23 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A064212-002 | DAUNORUBICIN HYDROCHLORIDE | EQ 50MG BASE/VIAL | INJECTABLE / INJECTION | 1999-05-03 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A064212-001 | DAUNORUBICIN HYDROCHLORIDE | EQ 20MG BASE/VIAL | INJECTABLE / INJECTION | 1998-06-23 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A064212-002 | DAUNORUBICIN HYDROCHLORIDE | EQ 50MG BASE/VIAL | INJECTABLE / INJECTION | 1999-05-03 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A064212-001 | DAUNORUBICIN HYDROCHLORIDE | EQ 20MG BASE/VIAL | INJECTABLE / INJECTION | 1998-06-23 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A064212-002 | DAUNORUBICIN HYDROCHLORIDE | EQ 50MG BASE/VIAL | INJECTABLE / INJECTION | 1999-05-03 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A064212-001 | DAUNORUBICIN HYDROCHLORIDE | EQ 20MG BASE/VIAL | INJECTABLE / INJECTION | 1998-06-23 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A064212-002 | DAUNORUBICIN HYDROCHLORIDE | EQ 50MG BASE/VIAL | INJECTABLE / INJECTION | 1999-05-03 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A064212-001 | DAUNORUBICIN HYDROCHLORIDE | EQ 20MG BASE/VIAL | INJECTABLE / INJECTION | 1998-06-23 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A064212-002 | DAUNORUBICIN HYDROCHLORIDE | EQ 50MG BASE/VIAL | INJECTABLE / INJECTION | 1999-05-03 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A064212-001 | DAUNORUBICIN HYDROCHLORIDE | EQ 20MG BASE/VIAL | INJECTABLE / INJECTION | 1998-06-23 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A064212-002 | DAUNORUBICIN HYDROCHLORIDE | EQ 50MG BASE/VIAL | INJECTABLE / INJECTION | 1999-05-03 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A064212-001 | DAUNORUBICIN HYDROCHLORIDE | EQ 20MG BASE/VIAL | INJECTABLE / INJECTION | 1998-06-23 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A064212-002 | DAUNORUBICIN HYDROCHLORIDE | EQ 50MG BASE/VIAL | INJECTABLE / INJECTION | 1999-05-03 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A064212-001 | DAUNORUBICIN HYDROCHLORIDE | EQ 20MG BASE/VIAL | INJECTABLE / INJECTION | 1998-06-23 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A064212-002 | DAUNORUBICIN HYDROCHLORIDE | EQ 50MG BASE/VIAL | INJECTABLE / INJECTION | 1999-05-03 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A064212-001 | DAUNORUBICIN HYDROCHLORIDE | EQ 20MG BASE/VIAL | INJECTABLE / INJECTION | 1998-06-23 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A064212-002 | DAUNORUBICIN HYDROCHLORIDE | EQ 50MG BASE/VIAL | INJECTABLE / INJECTION | 1999-05-03 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A064212-001 | DAUNORUBICIN HYDROCHLORIDE | EQ 20MG BASE/VIAL | INJECTABLE / INJECTION | 1998-06-23 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A064212-002 | DAUNORUBICIN HYDROCHLORIDE | EQ 50MG BASE/VIAL | INJECTABLE / INJECTION | 1999-05-03 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A064212-001 | DAUNORUBICIN HYDROCHLORIDE | EQ 20MG BASE/VIAL | INJECTABLE / INJECTION | 1998-06-23 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A064212-002 | DAUNORUBICIN HYDROCHLORIDE | EQ 50MG BASE/VIAL | INJECTABLE / INJECTION | 1999-05-03 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A064212-001 | DAUNORUBICIN HYDROCHLORIDE | EQ 20MG BASE/VIAL | INJECTABLE / INJECTION | 1998-06-23 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A064212-002 | DAUNORUBICIN HYDROCHLORIDE | EQ 50MG BASE/VIAL | INJECTABLE / INJECTION | 1999-05-03 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A064212-001 | DAUNORUBICIN HYDROCHLORIDE | EQ 20MG BASE/VIAL | INJECTABLE / INJECTION | 1998-06-23 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A064212-002 | DAUNORUBICIN HYDROCHLORIDE | EQ 50MG BASE/VIAL | INJECTABLE / INJECTION | 1999-05-03 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A064212-001 | DAUNORUBICIN HYDROCHLORIDE | EQ 20MG BASE/VIAL | INJECTABLE / INJECTION | 1998-06-23 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A064212-002 | DAUNORUBICIN HYDROCHLORIDE | EQ 50MG BASE/VIAL | INJECTABLE / INJECTION | 1999-05-03 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A064212-001 | DAUNORUBICIN HYDROCHLORIDE | EQ 20MG BASE/VIAL | INJECTABLE / INJECTION | 1998-06-23 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A064212-002 | DAUNORUBICIN HYDROCHLORIDE | EQ 50MG BASE/VIAL | INJECTABLE / INJECTION | 1999-05-03 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A064212-001 | DAUNORUBICIN HYDROCHLORIDE | EQ 20MG BASE/VIAL | INJECTABLE / INJECTION | 1998-06-23 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A064212-002 | DAUNORUBICIN HYDROCHLORIDE | EQ 50MG BASE/VIAL | INJECTABLE / INJECTION | 1999-05-03 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A064212-001 | DAUNORUBICIN HYDROCHLORIDE | EQ 20MG BASE/VIAL | INJECTABLE / INJECTION | 1998-06-23 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A064212-002 | DAUNORUBICIN HYDROCHLORIDE | EQ 50MG BASE/VIAL | INJECTABLE / INJECTION | 1999-05-03 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A064212-001 | DAUNORUBICIN HYDROCHLORIDE | EQ 20MG BASE/VIAL | INJECTABLE / INJECTION | 1998-06-23 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A064212-002 | DAUNORUBICIN HYDROCHLORIDE | EQ 50MG BASE/VIAL | INJECTABLE / INJECTION | 1999-05-03 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A064212-001 | DAUNORUBICIN HYDROCHLORIDE | EQ 20MG BASE/VIAL | INJECTABLE / INJECTION | 1998-06-23 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A064212-002 | DAUNORUBICIN HYDROCHLORIDE | EQ 50MG BASE/VIAL | INJECTABLE / INJECTION | 1999-05-03 | 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 |
|---|---|---|---|---|---|---|
| Daunorubicin Hydrochloride | DAUNORUBICIN HYDROCHLORIDE | Hisun Pharmaceuticals USA, Inc. | 9705fa12-499e-41a3-8fb4-f6df0858b851 | 2026-01-19 | Boxed warning, Warnings, Adverse reactions | Daunorubicin Hydrochloride DAUNORUBICIN HYDROCHLORIDE |
| daunorubicin hydrochloride | DAUNORUBICIN HYDROCHLORIDE | Meitheal Pharmaceuticals Inc. | ff6b9bd4-8a9f-400f-a0b9-70e25fa8a28f | 2025-05-21 | Boxed warning, Warnings, Adverse reactions | daunorubicin hydrochloride DAUNORUBICIN HYDROCHLORIDE |
| Daunorubicin Hydrochloride | DAUNORUBICIN HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 227784a8-ce68-4dd4-8ac5-a65265969677 | 2024-02-15 | Boxed warning, Warnings, Adverse reactions | Daunorubicin Hydrochloride DAUNORUBICIN HYDROCHLORIDE |
| Daunorubicin Hydrochloride | DAUNORUBICIN HYDROCHLORIDE | Hisun Pharmaceuticals USA, Inc. | f4312095-3c21-296b-e053-2995a90a0d9c | 2023-01-01 | Boxed warning, Warnings, Adverse reactions | Daunorubicin Hydrochloride DAUNORUBICIN HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8359 | ORIG | 1998-06-23 |