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Details for New Drug Application (NDA): 205437

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NDA 205437 describes OTEZLA, which is a drug marketed by Celgene Corp and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the OTEZLA profile page.

The generic ingredient in OTEZLA is apremilast. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the apremilast profile page.

Summary for NDA: 205437

Tradename:
OTEZLA
Applicant:
Celgene Corp
Ingredient:
apremilast
Patents:9
Formulation / Manufacturing:see details

Pharmacology for NDA: 205437

Suppliers and Packaging for NDA: 205437

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OTEZLA
apremilast
TABLET;ORAL 205437 NDA Celgene Corporation 59572-630 59572-630-27 1 KIT in 1 BLISTER PACK (59572-630-27)
OTEZLA
apremilast
TABLET;ORAL 205437 NDA Celgene Corporation 59572-630 59572-630-99 1 KIT in 1 BLISTER PACK (59572-630-99)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Mar 21, 2014TE:RLD:No
Patent:7,427,638Patent Expiration:Nov 17, 2024Product Flag?YSubstance Flag?YDelist Request?
Patent:7,893,101Patent Expiration:Dec 9, 2023Product Flag?YSubstance Flag?YDelist Request?
Regulatory Exclusivity Expiration:Mar 21, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY


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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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