Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 208552
Company: MAYNE PHARMA

Products on NDA 208552

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RHOFADE	OXYMETAZOLINE HYDROCHLORIDE	1%	CREAM;TOPICAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208552

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/18/2017	ORIG-1	Approval		STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208552s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208552Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208552Orig1s000TOC.html

Labels for NDA 208552

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/18/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208552s000lbl.pdf

Therapeutic Equivalents for NDA 208552

RHOFADE

CREAM;TOPICAL; 1%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OXYMETAZOLINE HYDROCHLORIDE	OXYMETAZOLINE HYDROCHLORIDE	1%	CREAM;TOPICAL	Prescription	No	AB	213584	SUN PHARMA CANADA
RHOFADE	OXYMETAZOLINE HYDROCHLORIDE	1%	CREAM;TOPICAL	Prescription	Yes	AB	208552	MAYNE PHARMA