Is Amryt Pharmaceuticals DAC FDA approved?

Amryt Pharmaceuticals DAC holds no registered establishment of its own; 3 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Amryt Pharmaceuticals DAC make?

3 products are listed under Amryt Pharmaceuticals DAC in the openFDA NDC Directory, most often as capsule; gel. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Amryt Pharmaceuticals DAC

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

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Registered sites: 0
Active NDC listings: 3
Live patents: 0
Countries: 0

Catalogue

Drug listings by form and route

3 active NDC listings: 3 human prescription drug. By marketing category: NDA 3.

Dosage form	NDCs
capsule	2
gel	1

Route	NDCs
oral	2
topical	1

Labeller name on the listing	NDCs
amryt pharmaceuticals dac	3

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
FILSUVEZ	birch triterpenes	gel, topical	76431-310NDA
Juxtapid	lomitapide mesylate	capsule, oral	76431-110NDA
Juxtapid	lomitapide mesylate	capsule, oral	76431-120NDA

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Other companies listing lomitapide mesylate

Chiesi USA, Inc.1 site · 25 NDC

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Common questions

Is Amryt Pharmaceuticals DAC FDA approved?: Amryt Pharmaceuticals DAC holds no registered establishment of its own; 3 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Amryt Pharmaceuticals DAC make?: 3 products are listed under Amryt Pharmaceuticals DAC in the openFDA NDC Directory, most often as capsule; gel. 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.