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Generated: July 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208032

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NDA 208032 describes KOVANAZE, which is a drug marketed by St Renatus and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the KOVANAZE profile page.

The generic ingredient in KOVANAZE is oxymetazoline hydrochloride; tetracaine 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; tetracaine hydrochloride profile page.
Summary for 208032
Tradename:KOVANAZE
Applicant:St Renatus
Ingredient:oxymetazoline hydrochloride; tetracaine hydrochloride
Patents:3
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 208032
Generic Entry Date for 208032*:
Constraining patent/regulatory exclusivity:
NEW COMBINATION
Dosage::
SPRAY, METERED;NASAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 208032
Suppliers and Packaging for NDA: 208032
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KOVANAZE oxymetazoline hydrochloride; tetracaine hydrochloride SPRAY, METERED;NASAL 208032 NDA St. Renatus 69803-100 N 69803-100-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength0.1MG/SPRAY;6MG/SPRAY
Approval Date:Jun 29, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 29, 2019
Regulatory Exclusivity Use:NEW COMBINATION
Patent:➤ Sign UpPatent Expiration:Mar 20, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF ANESTHETIZING AT LEAST A PORTION OF THE MAXILLARY DENTAL ARCH
Patent:➤ Sign UpPatent Expiration:Apr 2, 2030Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF ANESTHETIZING AT LEAST A PORTION OF THE MAXILLARY DENTAL ARCH

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