Active ingredient
Momelotinib
3 finished FDA listings contain Momelotinib as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- MOMELOTINIB, MOMELOTINIB DIHYDROCHLORIDE MONOHYDRATE
- Dosage forms
- Tablet
- Routes
- Oral
- Manufacturers / labelers
- 1
- Strengths listed
- 100 mg/1 · 150 mg/1 · 200 mg/1
- Brand names in FDA listings
- Ojjaara
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2665204
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 216873 | GLAXOSMITHKLINE | 2023-09-15 | 3 |
Official labeling on DailyMed
- OJJAARA (MOMELOTINIB) TABLET [GLAXOSMITHKLINE LLC] · version 9 · 2026-07-31
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.