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Serving 500+ biopharmaceutical companies globally:

Medtronic
QuintilesIMS
Fish and Richardson
Teva
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Dow
Johnson and Johnson
Queensland Health
UBS
Moodys

Generated: September 25, 2017

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 NDA: 208032

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:3
Formulation / Manufacturing:see details

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 69803-100-10 30 APPLICATOR in 1 CARTON (69803-100-10) > .2 mL in 1 APPLICATOR

Summary 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:► SubscribePatent Expiration:Mar 20, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF ANESTHETIZING AT LEAST A PORTION OF THE MAXILLARY DENTAL ARCH
Patent:► SubscribePatent 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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Serving 500+ biopharmaceutical companies globally:

Johnson and Johnson
US Army
Accenture
Mallinckrodt
Harvard Business School
US Department of Justice
McKinsey
Express Scripts
Federal Trade Commission
QuintilesIMS

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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