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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 209920

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NDA 209920 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 are ten drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the lubiprostone profile page.

Summary for 209920

Tradename:	LUBIPROSTONE
Applicant:	Teva Pharms Usa Inc
Ingredient:	lubiprostone
Patents:	0

Pharmacology for NDA: 209920

Mechanism of Action	Chloride Channel Activators

Medical Subject Heading (MeSH) Categories for 209920

Chloride Channel Agonists

Suppliers and Packaging for NDA: 209920

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LUBIPROSTONE	lubiprostone	CAPSULE;ORAL	209920	ANDA	Teva Pharmaceuticals, Inc.	0480-3479	0480-3479-06	60 CAPSULE, GELATIN COATED in 1 BOTTLE (0480-3479-06)
LUBIPROSTONE	lubiprostone	CAPSULE;ORAL	209920	ANDA	Teva Pharmaceuticals, Inc.	0480-4138	0480-4138-06	60 CAPSULE, GELATIN COATED in 1 BOTTLE (0480-4138-06)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	8MCG
Approval Date:	Jan 18, 2022	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	24MCG
Approval Date:	Jan 18, 2022	TE:	AB	RLD:	No

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