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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 206994

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NDA 206994 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 206994

Tradename:	LUBIPROSTONE
Applicant:	Dr Reddys
Ingredient:	lubiprostone
Patents:	0

Medical Subject Heading (MeSH) Categories for 206994

Chloride Channel Agonists

Profile for product number 001

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

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	24MCG
Approval Date:	Feb 8, 2022	TE:	AB	RLD:	No

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