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Details for New Drug Application (NDA): 203794

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NDA 203794 describes NUCYNTA, which is a drug marketed by Depomed Inc and is included in three NDAs. It is available from seven suppliers. There are eight patents protecting this drug and four Paragraph IV challenges. Additional details are available on the NUCYNTA profile page.

The generic ingredient in NUCYNTA is tapentadol hydrochloride. There are four drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the tapentadol hydrochloride profile page.

Summary for NDA: 203794

Tradename:
NUCYNTA
Applicant:
Depomed Inc
Ingredient:
tapentadol hydrochloride
Patents:3
Formulation / Manufacturing:see details

Pharmacology for NDA: 203794

Mechanism of ActionOpioid Agonists

Suppliers and Packaging for NDA: 203794

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NUCYNTA
tapentadol hydrochloride
SOLUTION;ORAL 203794 NDA Janssen Pharmaceuticals, Inc. 50458-817 50458-817-01 100 mL in 1 BOTTLE (50458-817-01)
NUCYNTA
tapentadol hydrochloride
SOLUTION;ORAL 203794 NDA Janssen Pharmaceuticals, Inc. 50458-817 50458-817-02 200 mL in 1 BOTTLE (50458-817-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrengthEQ 20MG BASE/ML
Approval Date:Oct 15, 2012TE:RLD:Yes
Patent:6,071,970Patent Expiration:Jun 6, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:MANAGEMENT OF MODERATE TO SEVERE ACUTE PAIN
Patent:7,994,364Patent Expiration:Jun 27, 2025Product Flag?YSubstance Flag?YDelist Request?
Patented Use:MANAGEMENT OF MODERATE TO SEVERE ACUTE PAIN
Patent:RE39593Patent Expiration:Aug 5, 2022Product Flag?YSubstance Flag?YDelist Request?
Patented Use:MANAGEMENT OF MODERATE TO SEVERE ACUTE PAIN


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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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