Active ingredient
Lapatinib
4 finished FDA listings contain Lapatinib as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- LAPATINIB, LAPATINIB DITOSYLATE
- Dosage forms
- Tablet, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 4
- Strengths listed
- 250 mg/1
- Brand names in FDA listings
- Tykerb
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 480167
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 022059 | NOVARTIS | 2007-03-13 | 1 |
| ANDA 203007 | NATCO PHARMA LTD | 2020-09-29 | 1 |
| ANDA 217968 | TEVA PHARMS USA INC | 2024-08-16 | 2 |
Official labeling on DailyMed
- TYKERB (LAPATINIB) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION] · version 14 · 2026-01-28
- LAPATINIB TABLET [LUPIN PHARMACEUTICALS, INC. ] · version 4 · 2025-06-16
- LAPATINIB TABLET, FILM COATED [AVKARE] · version 1 · 2025-03-17
- LAPATINIB TABLET, FILM COATED [TEVA PHARMACEUTICALS, INC.] · version 7 · 2025-01-01
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.