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Details for New Drug Application (NDA): 204427

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NDA 204427 describes KERYDIN, which is a drug marketed by Anacor Pharms Inc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the KERYDIN profile page.

The generic ingredient in KERYDIN is tavaborole. One supplier is listed for this compound. Additional details are available on the tavaborole profile page.

Summary for NDA: 204427

Tradename:
KERYDIN
Applicant:
Anacor Pharms Inc
Ingredient:
tavaborole
Patents:2
Formulation / Manufacturing:see details

Pharmacology for NDA: 204427

Ingredient-typeBoron Compounds
Mechanism of ActionProtein Synthesis Inhibitors

Suppliers and Packaging for NDA: 204427

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KERYDIN
tavaborole
SOLUTION;TOPICAL 204427 NDA PharmaDerm, A division of Fougera Pharmaceuticals Inc. 10337-905 10337-905-10 1 BOTTLE, WITH APPLICATOR in 1 CARTON (10337-905-10) > 10 mL in 1 BOTTLE, WITH APPLICATOR
KERYDIN
tavaborole
SOLUTION;TOPICAL 204427 NDA PharmaDerm, A division of Fougera Pharmaceuticals Inc. 10337-905 10337-905-44 1 BOTTLE, WITH APPLICATOR in 1 CARTON (10337-905-44) > 4 mL in 1 BOTTLE, WITH APPLICATOR

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength5%
Approval Date:Jul 7, 2014TE:RLD:Yes
Patent:7,767,657Patent Expiration:May 22, 2027Product Flag?YSubstance Flag?Delist Request?
Regulatory Exclusivity Expiration:Jul 7, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:7,582,621Patent Expiration:May 26, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF FUNGAL INFECTIONS


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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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