Labeler · US market

Supernus Pharmaceuticals, Inc.

Supernus Pharmaceuticals, Inc. is a US drug labeler with US FDA registrations covering 4 drug concepts (4 currently active) across 48 packages. It is currently the only active US supplier of 1 drug. The company files with FDA under 2 name variants, merged into this profile.

Also files as: Supernus Pharmaceuticals

ACTIVE — US

openFDA · updated weekly

Labeler codes17772

Active drugs4

Registrations12 active / 12

Packages48

Sole supplier of1 drugs

Portfolio4 drugs · US

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

Drug	Type	NDCs	Packages	Status
Topiramate capsule, extended release	rx	4	20	SUPPLYING
Viloxazine Hydrochloride capsule, extended release	rx	3	15	SUPPLYING
Oxcarbazepine tablet	rx	3	9	SUPPLYING
Amantadine capsule, coated pellets	rx	2	4	SUPPLYING

Sole US supplier

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

Viloxazine Hydrochloriderx

At a glance

TypeLabeler
Labeler codes17772
Filing names2
Drugs (active)4
Drugs (all time)4
US registrations12
Packages48

Recent events

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

Jul 12, 2016
RECALLRecall (Class II): Trokendi XR (topiramate) extended-release capsule, 50mg, 30-count blister pack, Rx only, Manufactured by: Catalent Phar…

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 (see “Also files as” above); figures cover the entity across all its filing names.