Active ingredient
Paclitaxel
44 finished FDA listings contain Paclitaxel as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- PACLITAXEL
- Dosage forms
- Injection, Injection, Powder, Lyophilized, For Suspension, Injection, Solution, Injection, Solution, Concentrate
- Routes
- Intravenous
- Manufacturers / labelers
- 23
- Strengths listed
- 100 mg/100mg · 100 mg/20ml · 6 mg/ml
- Brand names in FDA listings
- Abraxane, Paclitaxel, Paclitaxel 100mg Per Vial, Paclitaxel Paclitaxel, Paclitaxel Protein Bound Particles Albumin Bound, Paclitaxel Protein-Bound Particles For Injectable Suspension (Albumin-Bound)
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 56946
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 075184 | TEVA PHARMS | 2002-01-25 | 7 |
| ANDA 076131 | HOSPIRA | 2002-05-08 | 2 |
| NDA 021660 | BRISTOL-MYERS | 2005-01-07 | 1 |
| ANDA 077574 | FRESENIUS KABI USA | 2006-11-27 | 1 |
| ANDA 091540 | NATCO PHARMA USA | 2011-09-29 | 3 |
| ANDA 207326 | GLAND | 2016-08-23 | 7 |
| ANDA 213434 | MSN | 2020-08-24 | 6 |
| NDA 211875 | AM REGENT | 2022-07-27 | 1 |
| ANDA 216874 | ALEMBIC | 2022-10-20 | 7 |
| NDA 216338 | TEVA PHARMS INC | 2023-05-11 | 1 |
| ANDA 212700 | HENGRUI PHARMA | 2024-10-08 | 1 |
| ANDA 209657 | CIPLA | 2025-04-10 | 2 |
| ANDA 216355 | SHUANGCHENG | 2025-05-15 | 4 |
| ANDA 217877 | MYLAN | 2025-08-19 | 1 |
Official labeling on DailyMed
- PACLITAXEL INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] · version 12 · 2026-09-10
- PACLITAXEL 100MG PER VIAL (PACLITAXEL PROTEIN-BOUND PARTICLES) INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION [EXELAN PHARMACEUTICALS INC.] · version 1 · 2026-08-11
- PACLITAXEL INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] · version 8 · 2026-07-27
- PACLITAXEL INJECTION, SOLUTION [HOSPIRA, INC.] · version 33 · 2026-07-03
- PACLITAXEL INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION [MYLAN INSTITUTIONAL LLC] · version 4 · 2026-07-01
- PACLITAXEL INJECTION [BLUEPOINT LABORATORIES] · version 2 · 2026-05-25
- PACLITAXEL INJECTION, SOLUTION [BRYANT RANCH PREPACK] · version 100 · 2026-05-11
- ABRAXANE (PACLITAXEL) INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION [ABRAXIS BIOSCIENCE, LLC] · version 37 · 2026-04-06
- PACLITAXEL (PACLITAXEL (AIBUMIN-BOUND)) INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION [NINGBO SHUANGCHENG PHARMACEUTICAL CO., LTD] · version 5 · 2026-02-12
- PACLITAXEL INJECTION, SOLUTION [NATCO PHARMA USA LLC] · version 3 · 2026-01-23
- PACLITAXEL INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION [TEVA PHARMACEUTICALS, INC.] · version 4 · 2026-01-05
- PACLITAXEL PACLITAXEL (PACLITAXEL) INJECTION, SOLUTION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] · version 3 · 2025-11-17
Showing the 12 most recent of 26 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.