Labeler · US market

LEO Pharma Inc.

LEO Pharma Inc. is a US drug labeler with US FDA registrations covering 6 drug concepts (6 currently active) across 20 packages. It is currently the only active US supplier of 5 drugs.

ACTIVE — US

openFDA · updated weekly

Labeler codes50222

Active drugs6

Registrations9 active / 9

Packages20

Sole supplier of5 drugs

Portfolio6 drugs · US

Every drug concept this labeler has US registrations for, by package count.

Drug	Type	NDCs	Packages	Status
Tralokinumab-Ldrm injection, solution	rx	2	6	SUPPLYING
Spesolimab injection	rx	3	4	SUPPLYING
Calcipotriene And Betamethasone Dipropionate aerosol, foam	rx	1	3	SUPPLYING
Delgocitinib cream	rx	1	3	SUPPLYING
Calcipotriene And Betamethasone Dipropionate suspension	rx	1	2	SUPPLYING
Azelaic Acid aerosol, foam	rx	1	2	SUPPLYING

Sole US supplier

Drugs where this labeler is currently the only active US supplier — a single point of failure if it exits.

At a glance

TypeLabeler
Labeler codes50222
Filing names1
Drugs (active)6
Drugs (all time)6
US registrations9
Packages20

Recent events

Shortages, recalls, and registration changes across all filing names.

Feb 10, 2026
RECALLRecall (Class II): Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC…
Jan 19, 2017
RECALLRecall (Class II): Calcipotriene Cream 0.0005%, packaged in a) 60g tube, (NDC 66993-877-61), b) 120g tube (NDC 66993-877-78), Rx Only, Ma…
Jan 16, 2017
RECALLRecall (Class III): Taclonex (calcipotriene and betamethasone dipropionate) Topical Suspension, 0.005%/0.064%, packaged in (a) 60 g (NDC 5…

Watch this company

Alerts for recalls, exits, and new registrations.

Facility locations, FDA inspections, and parent-company mapping are on the roadmap. Name variants reported to FDA under different spellings are merged into this profile; figures cover the entity across all its filing names.