Application 216355
- Type
- ANDA
- Sponsor
- SHUANGCHENG
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PACLITAXEL | PACLITAXEL | POWDER;INTRAVENOUS | 100MG/VIAL | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A216355-001 | PACLITAXEL | PACLITAXEL | 100MG/VIAL | POWDER / INTRAVENOUS | AB | 2025-05-15 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A216355-001 | 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 | A216355-001 | PACLITAXEL | 100MG/VIAL | POWDER / INTRAVENOUS | AB | 2025-05-15 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216355-001 | PACLITAXEL | 100MG/VIAL | POWDER / INTRAVENOUS | AB | 2025-05-15 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216355-001 | PACLITAXEL | 100MG/VIAL | POWDER / INTRAVENOUS | AB | 2025-05-15 | 6a471c1ec25d… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216355-001 | PACLITAXEL | 100MG/VIAL | POWDER / INTRAVENOUS | AB | 2025-05-15 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A216355-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216355-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A216355-001 | AB | 1 | 6a471c1ec25d… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216355-001 | AB | 1 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| Paclitaxel | PACLITAXEL (AIBUMIN-BOUND) | Ningbo Shuangcheng Pharmaceutical Co., Ltd | 4df3fda6-0b29-420e-ab91-81441ce914ed | 2026-02-11 | Boxed warning, Warnings, Adverse reactions | 216355 ANDA216355 |
| Paclitaxel protein-bound particles for injectable suspension (albumin-bound) | PACLITAXEL | NorthStar Rx LLC | 1e9d5093-fbfc-470a-8520-811c46a8870c | 2025-09-17 | Boxed warning, Warnings, Adverse reactions | 216355 ANDA216355 |
| Paclitaxel protein-bound particles for injectable suspension (albumin-bound) | PACLITAXEL | BluePoint Laboratories | 36d4a2ed-4b34-4b06-e063-6394a90acc86 | 2025-08-13 | Boxed warning, Warnings, Adverse reactions | 216355 ANDA216355 |
| Paclitaxel protein-bound particles for injectable suspension (albumin-bound) | PACLITAXEL | Meitheal Pharmaceuticals Inc. | 31e893aa-8d9e-4576-8614-eb2fe772bde4 | 2025-05-22 | Boxed warning, Warnings, Adverse reactions | 216355 ANDA216355 |