Last Updated: September 24, 2026

Details for New Drug Application (NDA): 209450

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NDA 209450 describes LUBIPROSTONE, which is a drug marketed by Amneal, Ascent Pharms Inc, Dr Reddys, Ph Health, Teva Pharms Usa Inc, and Zydus Pharms, and is included in six NDAs. It is available from ten suppliers. Additional details are available on the LUBIPROSTONE profile page.

The generic ingredient in LUBIPROSTONE is lubiprostone. There is one drug master file entry for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the lubiprostone profile page.

Summary for 209450

Tradename:	LUBIPROSTONE
Applicant:	Amneal
Ingredient:	lubiprostone
Patents:	0

Medical Subject Heading (MeSH) Categories for 209450

Chloride Channel Agonists

Suppliers and Packaging for NDA: 209450

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LUBIPROSTONE	lubiprostone	CAPSULE;ORAL	209450	ANDA	Amneal Pharmaceuticals LLC	65162-841	65162-841-06	60 CAPSULE in 1 BOTTLE (65162-841-06)
LUBIPROSTONE	lubiprostone	CAPSULE;ORAL	209450	ANDA	Amneal Pharmaceuticals LLC	65162-841	65162-841-18	180 CAPSULE in 1 BOTTLE (65162-841-18)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	8MCG
Approval Date:	Nov 30, 2021	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	24MCG
Approval Date:	Nov 30, 2021	TE:	AB	RLD:	No

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