Active ingredient
Ponatinib
4 finished FDA listings contain Ponatinib as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- PONATINIB HYDROCHLORIDE
- Dosage forms
- Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 1
- Strengths listed
- 10 mg/1 · 15 mg/1 · 30 mg/1 · 45 mg/1
- Brand names in FDA listings
- Iclusig
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1364347
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 |
|---|---|---|---|
| NDA 203469 | TAKEDA PHARMS USA | 2012-12-14 | 4 |
Official labeling on DailyMed
- ICLUSIG (PONATINIB HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.] · version 20 · 2026-08-19
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.