FDA approved the original new drug application for PACLITAXEL on May 11, 2023, sponsored by TEVA PHARMS INC. FDA has approved 1 efficacy supplement on the application since, the most recent on November 21, 2023.
- Application
- NDA216338
- Sponsor
- TEVA PHARMS INC
- Original approval
- Review
- standard review
- Submission class
- Type 5 - New Formulation or New Manufacturer
- Active ingredient
- paclitaxel
Browse every approval whose brand starts with P, or the complete response letters FDA has published — the applications it did not approve.
Products under this application
| Ingredient and strength | Form | Route | Marketing status |
|---|---|---|---|
| paclitaxel 100MG/VIAL | POWDER | INTRAVENOUS | Prescription |
Approved efficacy supplements
An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.
| Approved | Supplement | Review |
|---|---|---|
| S-1 | standard |
Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.
Other approvals to TEVA PHARMS INC
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