Application 202356
- Type
- NDA
- Sponsor
- PFIZER LABS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DOCETAXEL | DOCETAXEL | INJECTABLE;INJECTION | 20MG/2ML (10MG/ML) | No | No |
| 002 | DOCETAXEL | DOCETAXEL | INJECTABLE;INJECTION | 80MG/8ML (10MG/ML) | No | No |
| 003 | DOCETAXEL | DOCETAXEL | INJECTABLE;INJECTION | 130MG/13ML (10MG/ML) | No | No |
| 004 | DOCETAXEL | DOCETAXEL | INJECTABLE;INJECTION | 200MG/20ML (10MG/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N202356-001 | DOCETAXEL | DOCETAXEL | 20MG/2ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 | ||
| N202356-002 | DOCETAXEL | DOCETAXEL | 80MG/8ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 | ||
| N202356-003 | DOCETAXEL | DOCETAXEL | 130MG/13ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 | ||
| N202356-004 | DOCETAXEL | DOCETAXEL | 200MG/20ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N202356-001 | DOCETAXEL | 20MG/2ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N202356-002 | DOCETAXEL | 80MG/8ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N202356-003 | DOCETAXEL | 130MG/13ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N202356-004 | DOCETAXEL | 200MG/20ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N202356-001 | DOCETAXEL | 20MG/2ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N202356-002 | DOCETAXEL | 80MG/8ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N202356-003 | DOCETAXEL | 130MG/13ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N202356-004 | DOCETAXEL | 200MG/20ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N202356-001 | DOCETAXEL | 20MG/2ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N202356-002 | DOCETAXEL | 80MG/8ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N202356-003 | DOCETAXEL | 130MG/13ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N202356-004 | DOCETAXEL | 200MG/20ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202356-001 | DOCETAXEL | 20MG/2ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202356-002 | DOCETAXEL | 80MG/8ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202356-003 | DOCETAXEL | 130MG/13ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202356-004 | DOCETAXEL | 200MG/20ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N202356-001 | DOCETAXEL | 20MG/2ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N202356-002 | DOCETAXEL | 80MG/8ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N202356-003 | DOCETAXEL | 130MG/13ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N202356-004 | DOCETAXEL | 200MG/20ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202356-001 | DOCETAXEL | 20MG/2ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202356-002 | DOCETAXEL | 80MG/8ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202356-003 | DOCETAXEL | 130MG/13ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202356-004 | DOCETAXEL | 200MG/20ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202356-001 | DOCETAXEL | 20MG/2ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202356-002 | DOCETAXEL | 80MG/8ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202356-003 | DOCETAXEL | 130MG/13ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202356-004 | DOCETAXEL | 200MG/20ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202356-001 | DOCETAXEL | 20MG/2ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202356-002 | DOCETAXEL | 80MG/8ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202356-003 | DOCETAXEL | 130MG/13ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202356-004 | DOCETAXEL | 200MG/20ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202356-001 | DOCETAXEL | 20MG/2ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202356-002 | DOCETAXEL | 80MG/8ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202356-003 | DOCETAXEL | 130MG/13ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202356-004 | DOCETAXEL | 200MG/20ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202356-001 | DOCETAXEL | 20MG/2ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202356-002 | DOCETAXEL | 80MG/8ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202356-003 | DOCETAXEL | 130MG/13ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202356-004 | DOCETAXEL | 200MG/20ML (10MG/ML) | INJECTABLE / INJECTION | 2014-03-13 | 5bbf6a4d5a75… |
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 |
|---|---|---|---|---|---|---|
| Docetaxel | DOCETAXEL | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | e488100d-6728-4f44-9282-f63a805b8e13 | 2023-09-21 | Boxed warning, Warnings, Adverse reactions | Docetaxel DOCETAXEL |
| Docetaxel | DOCETAXEL ANHYDROUS | Mylan Institutional LLC | 2fb017fd-e55e-43ef-9024-07f2d412b37b | 2023-09-05 | Boxed warning, Warnings, Adverse reactions | Docetaxel |
| Docetaxel | DOCETAXEL | Alembic Pharmaceuticals Inc. | 3a49c281-8cfd-4698-a9df-90ba800058ef | 2023-09-04 | Boxed warning, Warnings, Adverse reactions | Docetaxel DOCETAXEL |
| Docetaxel | DOCETAXEL | Amneal Pharmaceuticals LLC | 67508df6-b96f-46fa-a792-0afcdfa9810e | 2023-08-20 | Boxed warning, Warnings, Adverse reactions | Docetaxel DOCETAXEL |
| Docetaxel | DOCETAXEL | Gland Pharma Limited | 14cbd8f6-e11b-4d64-aa4c-e70a2ecbf975 | 2023-06-16 | Boxed warning, Warnings, Adverse reactions | Docetaxel DOCETAXEL |
| Docetaxel | DOCETAXEL ANHYDROUS | Sagent Pharmaceuticals | 6b227144-c844-4549-960c-cc3ac5c13b2b | 2023-06-08 | Boxed warning, Warnings, Adverse reactions | Docetaxel |
| Docetaxel | DOCETAXEL | Alembic Pharmaceuticals Limited | 682a0b1a-3277-4718-a94e-9645633062bf | 2023-04-27 | Boxed warning, Warnings, Adverse reactions | Docetaxel DOCETAXEL |
| Docetaxel | DOCETAXEL | Sun Pharmaceutical Industries, Inc. | c85b2c62-3c33-4cbc-8b79-d5e17851a1b4 | 2021-02-04 | Boxed warning, Warnings, Adverse reactions | Docetaxel DOCETAXEL |
| Docetaxel | DOCETAXEL | Dr. Reddy's Laboratories Inc. | be3df07d-ea56-453a-25ad-c3cedc22712a | 2020-06-23 | Boxed warning, Warnings, Adverse reactions | Docetaxel DOCETAXEL |
| Docetaxel | DOCETAXEL | Dr. Reddy's Laboratories Inc. | a630937b-8369-74ad-b68a-f940eb16ff0f | 2020-06-23 | Boxed warning, Warnings, Adverse reactions | Docetaxel DOCETAXEL |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.