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Last Updated: July 18, 2024

Details for New Drug Application (NDA): 208552


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NDA 208552 describes RHOFADE, which is a drug marketed by Mayne Pharma and is included in one NDA. It is available from one supplier. There are eight 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. Three suppliers are listed for this compound. Additional details are available on the oxymetazoline hydrochloride profile page.
Summary for 208552
Tradename:RHOFADE
Applicant:Mayne Pharma
Ingredient:oxymetazoline hydrochloride
Patents:8
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 EPI Health, LLC 71403-003 71403-003-15 1 TUBE in 1 CARTON (71403-003-15) / 3 g in 1 TUBE
RHOFADE oxymetazoline hydrochloride CREAM;TOPICAL 208552 NDA EPI Health, LLC 71403-003 71403-003-30 1 TUBE in 1 CARTON (71403-003-30) / 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength1%
Approval Date:Jan 18, 2017TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Jun 11, 2035Product Flag?Substance Flag?Delist Request?
Patented Use:ONCE DAILY TOPICAL TREATMENT OF PERSISTENT FACIAL ERYTHEMA ASSOCIATED WITH ROSACEA IN ADULTS WITH 1% OXYMETAZOLINE HYDROCHLORIDE CREAM, WHERE THE PATIENT EXPERIENCES NO REBOUND OR WORSENING OF FACIAL ERYTHEMA POST-TREATMENT
Patent:⤷  Sign UpPatent Expiration:Jun 11, 2035Product Flag?Substance Flag?Delist Request?
Patented Use:ONCE DAILY TOPICAL TREATMENT OF PERSISTENT FACIAL ERYTHEMA ASSOCIATED WITH ROSACEA IN ADULTS
Patent:⤷  Sign UpPatent Expiration:Jun 11, 2035Product Flag?Substance Flag?Delist Request?
Patented Use:ONCE DAILY TOPICAL TREATMENT OF PERSISTENT FACIAL ERYTHEMA ASSOCIATED WITH ROSACEA IN FEMALE ADULTS

Expired US Patents for NDA 208552

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mayne Pharma RHOFADE oxymetazoline hydrochloride CREAM;TOPICAL 208552-001 Jan 18, 2017 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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