Application 061876
- Type
- ANDA
- Sponsor
- SANOFI AVENTIS US
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CERUBIDINE | DAUNORUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 20MG BASE/VIAL | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A061876-001 | CERUBIDINE | DAUNORUBICIN HYDROCHLORIDE | EQ 20MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A061876-001 | CERUBIDINE | EQ 20MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A061876-001 | CERUBIDINE | EQ 20MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A061876-001 | CERUBIDINE | EQ 20MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A061876-001 | CERUBIDINE | EQ 20MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | cb3db0bc1861… | ||
| 2026-08-01 22:54:32 | 2026-06 | A061876-001 | CERUBIDINE | EQ 20MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 | Meitheal Pharmaceuticals Inc. | ff6b9bd4-8a9f-400f-a0b9-70e25fa8a28f | 2025-05-21 | Boxed warning, Warnings, Adverse reactions | 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 | Hisun Pharmaceuticals USA, Inc. | f4312095-3c21-296b-e053-2995a90a0d9c | 2023-01-01 | Boxed warning, Warnings, Adverse reactions | DAUNORUBICIN HYDROCHLORIDE |