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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 214131

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NDA 214131 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 214131

Tradename:	LUBIPROSTONE
Applicant:	Zydus Pharms
Ingredient:	lubiprostone
Patents:	0

Pharmacology for NDA: 214131

Mechanism of Action	Chloride Channel Activators

Medical Subject Heading (MeSH) Categories for 214131

Chloride Channel Agonists

Suppliers and Packaging for NDA: 214131

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LUBIPROSTONE	lubiprostone	CAPSULE;ORAL	214131	ANDA	Zydus Pharmaceuticals USA Inc.	70710-1641	70710-1641-1	100 CAPSULE in 1 BOTTLE (70710-1641-1)
LUBIPROSTONE	lubiprostone	CAPSULE;ORAL	214131	ANDA	Zydus Pharmaceuticals USA Inc.	70710-1641	70710-1641-6	60 CAPSULE in 1 BOTTLE (70710-1641-6)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	8MCG
Approval Date:	Mar 23, 2023	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	24MCG
Approval Date:	Mar 23, 2023	TE:	AB	RLD:	No

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