Active ingredient
Mavacamten
4 finished FDA listings contain Mavacamten as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- MAVACAMTEN
- Dosage forms
- Capsule, Gelatin Coated
- Routes
- Oral
- Manufacturers / labelers
- 1
- Strengths listed
- 10 mg/1 · 15 mg/1 · 2.5 mg/1 · 5 mg/1
- Brand names in FDA listings
- Camzyos
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2600867
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 214998 | BRISTOL | 2022-04-28 | 4 |
Official labeling on DailyMed
- CAMZYOS (MAVACAMTEN) CAPSULE, GELATIN COATED [MYOKARDIA, INC.] · version 8 · 2025-05-01
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.