APPLICATION
NDA208552
TYPE
NDA
ORIGINAL APPROVAL
2017-01-18
LATEST ACTION
2017-01-18
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription
Products
RHOFADE · ReferencePrescription
OXYMETAZOLINE HYDROCHLORIDE 1% · CREAM · TOPICAL
Approval history
2017-01-18Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated · Original · standard — Letter ↗AP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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