Is there a generic for Lansoprazole; naproxen?

The FDA Orange Book does not currently list an approved generic (ANDA) for Lansoprazole; naproxen. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Lansoprazole; naproxen?

PREVACID NAPRAPAC 250 (COPACKAGED) (NDA 021507, TAKEDA PHARMS NA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Lansoprazole; naproxen are approved?

Lansoprazole; naproxen is approved in the following dosage form: capsule, delayed rel pellets, tablet.

FDA Orange Book · active-ingredient family

Lansoprazole; naproxen

Lansoprazole; naproxen is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:PREVACID NAPRAPAC 250 (COPACKAGED) · NDA 021507

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule, delayed rel pellets, tablet

Product	Applicant	Application	TE	Approved
PREVACID NAPRAPAC 250 (COPACKAGED)RLD×3	TAKEDA PHARMS NA	NDA 021507	—	Nov 14, 2003

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Lansoprazole; naproxen — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo