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 two suppliers. 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. Four 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

Pharmacology for NDA: 208552

Physiological Effect	Increased Sympathetic Activity Vasoconstriction

Medical Subject Heading (MeSH) Categories for 208552

Adrenergic alpha-Agonists
Nasal Decongestants
Sympathomimetics

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	Mayne Pharma	51862-765	51862-765-30	1 TUBE in 1 CARTON (51862-765-30) / 30 CREAM in 1 TUBE
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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	1%
Approval Date:	Jan 18, 2017	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Jun 11, 2035	Product 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 Up	Patent Expiration:	Jun 11, 2035	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	ONCE DAILY TOPICAL TREATMENT OF PERSISTENT FACIAL ERYTHEMA ASSOCIATED WITH ROSACEA IN ADULTS
Patent:	⤷ Sign Up	Patent Expiration:	Jun 11, 2035	Product 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

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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
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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