Application 218711
- Type
- NDA
- Sponsor
- ZHUHAI
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BEIZRAY | DOCETAXEL | SOLUTION;INTRAVENOUS | 80MG/4ML (20MG/ML) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N218711-001 | BEIZRAY | DOCETAXEL | 80MG/4ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-10-23 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N218711-001 | 11419842 | 2036-05-16 | U-4027 | Drug product | 2024-11-13 |
| N218711-001 | 11419842 | 2036-05-16 | U-4028 | Drug product | 2024-11-13 |
| N218711-001 | 11419842 | 2036-05-16 | U-881 | Drug product | 2024-11-13 |
| N218711-001 | 11419842 | 2036-05-16 | U-937 | Drug product | 2024-11-13 |
| N218711-001 | 11419842 | 2036-05-16 | U-946 | Drug product | 2024-11-13 |
| N218711-001 | 12090134 | 2036-05-16 | U-4027 | Drug product | 2024-11-13 |
| N218711-001 | 12090134 | 2036-05-16 | U-4028 | Drug product | 2024-11-13 |
| N218711-001 | 12090134 | 2036-05-16 | U-881 | Drug product | 2024-11-13 |
| N218711-001 | 12090134 | 2036-05-16 | U-937 | Drug product | 2024-11-13 |
| N218711-001 | 12090134 | 2036-05-16 | U-946 | Drug product | 2024-11-13 |
| N218711-001 | 12090135 | 2036-05-16 | Drug product | 2024-11-13 |
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 | N218711-001 | BEIZRAY | 80MG/4ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-10-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N218711-001 | BEIZRAY | 80MG/4ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-10-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N218711-001 | BEIZRAY | 80MG/4ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-10-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N218711-001 | BEIZRAY | 80MG/4ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-10-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N218711-001 | BEIZRAY | 80MG/4ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-10-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N218711-001 | BEIZRAY | 80MG/4ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-10-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N218711-001 | BEIZRAY | 80MG/4ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-10-23 | 2680178bc6a6… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N218711-001 | BEIZRAY | 80MG/4ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-10-23 | d8e5a09893c0… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N218711-001 | BEIZRAY | 80MG/4ML (20MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-10-23 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N218711-001 | 11419842 | 2036-05-16 | U-881 | Drug product | 2024-11-13 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N218711-001 | 11419842 | 2036-05-16 | U-937 | Drug product | 2024-11-13 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N218711-001 | 11419842 | 2036-05-16 | U-946 | Drug product | 2024-11-13 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N218711-001 | 11419842 | 2036-05-16 | U-4027 | Drug product | 2024-11-13 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N218711-001 | 11419842 | 2036-05-16 | U-4028 | Drug product | 2024-11-13 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N218711-001 | 12090134 | 2036-05-16 | U-881 | Drug product | 2024-11-13 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N218711-001 | 12090134 | 2036-05-16 | U-937 | Drug product | 2024-11-13 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N218711-001 | 12090134 | 2036-05-16 | U-946 | Drug product | 2024-11-13 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N218711-001 | 12090134 | 2036-05-16 | U-4027 | Drug product | 2024-11-13 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N218711-001 | 12090134 | 2036-05-16 | U-4028 | Drug product | 2024-11-13 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N218711-001 | 12090135 | 2036-05-16 | Drug product | 2024-11-13 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N218711-001 | 11419842 | 2036-05-16 | U-881 | Drug product | 2024-11-13 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N218711-001 | 11419842 | 2036-05-16 | U-937 | Drug product | 2024-11-13 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N218711-001 | 11419842 | 2036-05-16 | U-946 | Drug product | 2024-11-13 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N218711-001 | 11419842 | 2036-05-16 | U-4027 | Drug product | 2024-11-13 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N218711-001 | 11419842 | 2036-05-16 | U-4028 | Drug product | 2024-11-13 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N218711-001 | 12090134 | 2036-05-16 | U-881 | Drug product | 2024-11-13 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N218711-001 | 12090134 | 2036-05-16 | U-937 | Drug product | 2024-11-13 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N218711-001 | 12090134 | 2036-05-16 | U-946 | Drug product | 2024-11-13 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N218711-001 | 12090134 | 2036-05-16 | U-4027 | Drug product | 2024-11-13 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N218711-001 | 12090134 | 2036-05-16 | U-4028 | Drug product | 2024-11-13 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N218711-001 | 12090135 | 2036-05-16 | Drug product | 2024-11-13 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N218711-001 | 11419842 | 2036-05-16 | U-881 | Drug product | 2024-11-13 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N218711-001 | 11419842 | 2036-05-16 | U-937 | Drug product | 2024-11-13 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N218711-001 | 11419842 | 2036-05-16 | U-946 | Drug product | 2024-11-13 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N218711-001 | 11419842 | 2036-05-16 | U-4027 | Drug product | 2024-11-13 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N218711-001 | 11419842 | 2036-05-16 | U-4028 | Drug product | 2024-11-13 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N218711-001 | 12090134 | 2036-05-16 | U-881 | Drug product | 2024-11-13 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N218711-001 | 12090134 | 2036-05-16 | U-937 | Drug product | 2024-11-13 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N218711-001 | 12090134 | 2036-05-16 | U-946 | Drug product | 2024-11-13 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N218711-001 | 12090134 | 2036-05-16 | U-4027 | Drug product | 2024-11-13 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N218711-001 | 12090134 | 2036-05-16 | U-4028 | Drug product | 2024-11-13 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N218711-001 | 12090135 | 2036-05-16 | Drug product | 2024-11-13 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N218711-001 | 11419842 | 2036-05-16 | U-881 | Drug product | 2024-11-13 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N218711-001 | 11419842 | 2036-05-16 | U-937 | Drug product | 2024-11-13 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N218711-001 | 11419842 | 2036-05-16 | U-946 | Drug product | 2024-11-13 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N218711-001 | 11419842 | 2036-05-16 | U-4027 | Drug product | 2024-11-13 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N218711-001 | 11419842 | 2036-05-16 | U-4028 | Drug product | 2024-11-13 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N218711-001 | 12090134 | 2036-05-16 | U-881 | Drug product | 2024-11-13 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N218711-001 | 12090134 | 2036-05-16 | U-937 | Drug product | 2024-11-13 | fd3edfee7708… |
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 |
|---|---|---|---|---|---|---|
| BEIZRAY | DOCETAXEL | Zydus Pharmaceuticals USA Inc. | 8fb7d980-d6c7-468b-a9f0-adff16101a4b | 2025-12-17 | Boxed warning, Warnings, Adverse reactions | 218711 NDA218711 |
| BEIZRAY | DOCETAXEL | Zhuhai Beihai Biotech Co., Ltd. | 3538b979-8cac-49ed-b8dc-50f73ce38c72 | 2025-12-15 | Boxed warning, Warnings, Adverse reactions | 218711 NDA218711 |