Application 209657
- Type
- ANDA
- Sponsor
- CIPLA
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 |
|---|---|---|---|---|---|---|---|
| A209657-001 | PACLITAXEL | PACLITAXEL | 100MG/VIAL | POWDER / INTRAVENOUS | AB | 2025-04-10 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A209657-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A209657-001 | PACLITAXEL | 100MG/VIAL | POWDER / INTRAVENOUS | AB | 2025-04-10 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A209657-001 | PACLITAXEL | 100MG/VIAL | POWDER / INTRAVENOUS | AB | 2025-04-10 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209657-001 | PACLITAXEL | 100MG/VIAL | POWDER / INTRAVENOUS | AB | 2025-04-10 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209657-001 | PACLITAXEL | 100MG/VIAL | POWDER / INTRAVENOUS | AB | 2025-04-10 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209657-001 | PACLITAXEL | 100MG/VIAL | POWDER / INTRAVENOUS | AB | 2025-04-10 | 6a471c1ec25d… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209657-001 | PACLITAXEL | 100MG/VIAL | POWDER / INTRAVENOUS | AB | 2025-04-10 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A209657-001 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A209657-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A209657-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209657-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A209657-001 | AB | 1 | 6a471c1ec25d… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209657-001 | 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 100mg per vial | PACLITAXEL PROTEIN-BOUND PARTICLES | EXELAN PHARMACEUTICALS INC. | 135502ff-002c-4a29-ba93-60855cf44f31 | 2026-08-10 | Boxed warning, Warnings, Adverse reactions | 209657 ANDA209657 |
| Paclitaxel protein-bound particles | PACLITAXEL PROTEIN-BOUND PARTICLES | Cipla USA Inc. | 15eba86c-d9de-42e6-bc95-70ba4c015e72 | 2025-04-02 | Boxed warning, Warnings, Adverse reactions | 209657 ANDA209657 |