Is Sprout Pharmaceuticals, Inc. FDA approved?

Sprout Pharmaceuticals, Inc. holds no registered establishment of its own; 1 drug product is listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Sprout Pharmaceuticals, Inc. make?

1 product is listed under Sprout Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as tablet, film coated. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Sprout Pharmaceuticals, Inc.

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

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

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
7151103	ADDYIflibanserin	use	May 2028

Product	Exclusivity	Until
ADDYIFLIBANSERIN	I-983 New indication	Dec 2028

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
ADDYI	flibanserin	tablet, film coated, oral	58604-214NDA

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Common questions

Is Sprout Pharmaceuticals, Inc. FDA approved?: Sprout Pharmaceuticals, Inc. holds no registered establishment of its own; 1 drug product is listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Sprout Pharmaceuticals, Inc. make?: 1 product is listed under Sprout Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as tablet, film 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.