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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 201442

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NDA 201442 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 eight 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. Nineteen suppliers are listed for this compound. Additional details are available on the lubiprostone profile page.

Summary for 201442

Tradename:	LUBIPROSTONE
Applicant:	Ph Health
Ingredient:	lubiprostone
Patents:	0

Medical Subject Heading (MeSH) Categories for 201442

Chloride Channel Agonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	8MCG
Approval Date:	Jun 27, 2022	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	24MCG
Approval Date:	Jun 27, 2022	TE:		RLD:	No

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