Details for New Drug Application (NDA): 021214

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NDA 021214 describes RESCULA, which is a drug marketed by Sucampo Pharma Llc and is included in one NDA. Additional details are available on the RESCULA profile page.

The generic ingredient in RESCULA is unoprostone isopropyl. There are four drug master file entries for this compound. Additional details are available on the unoprostone isopropyl profile page.

Summary for 021214

Tradename:	RESCULA
Applicant:	Sucampo Pharma Llc
Ingredient:	unoprostone isopropyl
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.15% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Aug 3, 2000	TE:		RLD:	Yes

Expired US Patents for NDA 021214

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sucampo Pharma Llc	RESCULA	unoprostone isopropyl	SOLUTION/DROPS;OPHTHALMIC	021214-001	Aug 3, 2000	⤷ Sign Up	⤷ Sign Up
Sucampo Pharma Llc	RESCULA	unoprostone isopropyl	SOLUTION/DROPS;OPHTHALMIC	021214-001	Aug 3, 2000	⤷ Sign Up	⤷ Sign Up
Sucampo Pharma Llc	RESCULA	unoprostone isopropyl	SOLUTION/DROPS;OPHTHALMIC	021214-001	Aug 3, 2000	⤷ Sign Up	⤷ Sign Up
Sucampo Pharma Llc	RESCULA	unoprostone isopropyl	SOLUTION/DROPS;OPHTHALMIC	021214-001	Aug 3, 2000	⤷ Sign Up	⤷ Sign Up
Sucampo Pharma Llc	RESCULA	unoprostone isopropyl	SOLUTION/DROPS;OPHTHALMIC	021214-001	Aug 3, 2000	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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