Active ingredient
Lorlatinib
3 finished FDA listings contain Lorlatinib as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- LORLATINIB
- Dosage forms
- Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 2
- Strengths listed
- 100 mg/1 · 25 mg/1
- Brand names in FDA listings
- Lorbrena
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2103164
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 210868 | PFIZER | 2018-11-02 | 3 |
Official labeling on DailyMed
- LORBRENA (LORLATINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] · version 13 · 2026-06-29
- LORBRENA (LORLATINIB) TABLET, FILM COATED [U.S. PHARMACEUTICALS] · version 3 · 2026-02-18
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.