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Last Updated: November 4, 2024

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:DISCNDosage:SOLUTION/DROPS;OPHTHALMICStrength0.15% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Aug 3, 2000TE:RLD:Yes

Expired US Patents for NDA 021214

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
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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