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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. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. 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. One supplier is listed for this compound. Additional details are available on the unoprostone isopropyl profile page.

Summary for NDA: 021214

Tradename:
RESCULA
Applicant:
Sucampo Pharma Llc
Ingredient:
unoprostone isopropyl
Patents:2

Pharmacology for NDA: 021214

Ingredient-typeProstaglandins

Suppliers and Packaging for NDA: 021214

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RESCULA
unoprostone isopropyl
SOLUTION/DROPS;OPHTHALMIC 021214 NDA Sucampo Pharma Americas, LLC 17350-015 17350-015-05 5 mL in 1 BOTTLE, DROPPER (17350-015-05)

Summary 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Aug 3, 2000TE:RLD:No
Patent:6,770,675Patent Expiration:Nov 24, 2018Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF REDUCING OCULAR HYPERTENSION
Patent:6,458,836Patent Expiration:Jul 9, 2021Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING OCULAR HYPERTENSION
Patent:6,458,836Patent Expiration:Jul 9, 2021Product Flag?Substance Flag?Delist Request?
Patented Use:THE LONG TERM TREATMENT OF PROPHYLACTIC MANAGEMENT OF OCULAR HYPERTENSION AND GLAUCOMA

Expired Orange Book Patents for NDA: 021214

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sucampo Pharma Llc
RESCULA
unoprostone isopropyl
SOLUTION/DROPS;OPHTHALMIC021214-001Aug 3, 20005,001,153► subscribe
Sucampo Pharma Llc
RESCULA
unoprostone isopropyl
SOLUTION/DROPS;OPHTHALMIC021214-001Aug 3, 20005,212,200► subscribe
Sucampo Pharma Llc
RESCULA
unoprostone isopropyl
SOLUTION/DROPS;OPHTHALMIC021214-001Aug 3, 20005,208,256► subscribe
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