Is Scienture LLC FDA approved?

Scienture LLC holds no registered establishment of its own; 2 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Scienture LLC make?

2 products are listed under Scienture LLC in the openFDA NDC Directory, most often as spray; suspension. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Scienture LLC

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

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Registered sites: 0
Active NDC listings: 2
Live patents: 5
Exclusivities: 1
Countries: 0

Catalogue

Drug listings by form and route

2 active NDC listings: 2 human prescription drug. By marketing category: NDA 2.

Dosage form	NDCs
spray	1
suspension	1

Route	NDCs
nasal	1
oral	1

Labeller name on the listing	NDCs
scienture llc	2

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
12514854	REZENOPYnaloxone hydrochloride	use	Feb 2041
12622903	REZENOPYnaloxone hydrochloride	product	Feb 2041
11890273	ARBLIlosartan potassium	product	Oct 2041
12156869	ARBLIlosartan potassium	product	Oct 2041
12605365	ARBLIlosartan potassium	product	Oct 2041

Product	Exclusivity	Until
REZENOPYNALOXONE HYDROCHLORIDE	NP New product	Apr 2027

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
ARBLI	losartan potassium	suspension, oral	83245-053NDA
REZENOPY	naloxone HCl	spray, nasal	83245-003NDA

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Enquiry

Common questions

Is Scienture LLC FDA approved?: Scienture LLC holds no registered establishment of its own; 2 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Scienture LLC make?: 2 products are listed under Scienture LLC in the openFDA NDC Directory, most often as spray; suspension. 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.