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Generated: November 18, 2018

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Details for New Drug Application (NDA): 208552

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NDA 208552 describes RHOFADE, which is a drug marketed by Allergan Inc and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the RHOFADE profile page.

The generic ingredient in RHOFADE is oxymetazoline hydrochloride. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the oxymetazoline hydrochloride profile page.
Summary for 208552
Tradename:RHOFADE
Applicant:Allergan Inc
Ingredient:oxymetazoline hydrochloride
Patents:5
Formulation / Manufacturing:see details
Pharmacology for NDA: 208552
Medical Subject Heading (MeSH) Categories for 208552
Suppliers and Packaging for NDA: 208552
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RHOFADE oxymetazoline hydrochloride CREAM;TOPICAL 208552 NDA Allergan, Inc. 0023-5300 0023-5300-30 1 TUBE in 1 CARTON (0023-5300-30) > 30 g in 1 TUBE
RHOFADE oxymetazoline hydrochloride CREAM;TOPICAL 208552 NDA Allergan, Inc. 0023-5300 0023-5300-35 1 BOTTLE, PUMP in 1 CARTON (0023-5300-35) > 30 g in 1 BOTTLE, PUMP

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength1%
Approval Date:Jan 18, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 18, 2020
Regulatory Exclusivity Use:NEW PRODUCT
Patent:➤ Sign UpPatent Expiration:May 2, 2028Product Flag?Substance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF PERSISTENT FACIAL ERYTHEMA ASSOCIATED WITH ROSACEA IN ADULTS WITH 1% OXYMETAZOLINE HYDROCHLORIDE CREAM
Patent:➤ Sign UpPatent Expiration:Aug 2, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF PERSISTENT FACIAL ERYTHEMA ASSOCIATED WITH ROSACEA IN ADULTS WITH 1% OXYMETAZOLINE HYDROCHLORIDE CREAM

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