Is Myokardia, Inc. FDA approved?

Myokardia, Inc. holds no registered establishment of its own; 4 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Myokardia, Inc. make?

4 products are listed under Myokardia, Inc. in the openFDA NDC Directory, most often as capsule, gelatin coated. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Myokardia, Inc.

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 0
Active NDC listings: 4
Live patents: 0
Countries: 0

Catalogue

Drug listings by form and route

4 active NDC listings: 4 human prescription drug. By marketing category: NDA 4.

Dosage form	NDCs
capsule, gelatin coated	4

Route	NDCs
oral	4

Labeller name on the listing	NDCs
myokardia, inc.	4

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
CAMZYOS	mavacamten	capsule, gelatin coated, oral	73625-111NDA
CAMZYOS	mavacamten	capsule, gelatin coated, oral	73625-112NDA
CAMZYOS	mavacamten	capsule, gelatin coated, oral	73625-113NDA
CAMZYOS	mavacamten	capsule, gelatin coated, oral	73625-114NDA

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Other companies listing mavacamten

Patheon Manufacturing Services LLC19 sites · 319 NDC

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Common questions

Is Myokardia, Inc. FDA approved?: Myokardia, Inc. holds no registered establishment of its own; 4 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Myokardia, Inc. make?: 4 products are listed under Myokardia, Inc. in the openFDA NDC Directory, most often as capsule, gelatin coated. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.