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Generated: November 20, 2018

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Details for New Drug Application (NDA): 022304

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NDA 022304 describes NUCYNTA, which is a drug marketed by Depomed Inc and Depo Nf and is included in three NDAs. It is available from four suppliers. There are seven 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 five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the tapentadol hydrochloride profile page.
Summary for 022304
Tradename:NUCYNTA
Applicant:Depo Nf
Ingredient:tapentadol hydrochloride
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 022304
Mechanism of ActionOpioid Agonists
Suppliers and Packaging for NDA: 022304
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304 NDA Rebel Distributors Corp 21695-069 21695-069-72 120 TABLET, FILM COATED in 1 BOTTLE (21695-069-72)
NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304 NDA Lake Erie Medical DBA Quality Care Products LLC 35356-525 35356-525-30 30 TABLET in 1 BOTTLE, PLASTIC (35356-525-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Nov 20, 2008TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Jun 27, 2025Product Flag?YSubstance Flag?YDelist Request?
Patented Use:RELIEF OF MODERATE TO SEVERE ACUTE PAIN
Patent:➤ Sign UpPatent Expiration:Aug 5, 2022Product Flag?YSubstance Flag?YDelist Request?
Patented Use:RELIEF OF MODERATE TO SEVERE ACUTE PAIN

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 75MG BASE
Approval Date:Nov 20, 2008TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Jun 27, 2025Product Flag?YSubstance Flag?YDelist Request?
Patented Use:RELIEF OF MODERATE TO SEVERE ACUTE PAIN

Expired US Patents for NDA 022304

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Depo Nf NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-001 Nov 20, 2008 ➤ Sign Up ➤ Sign Up
Depo Nf NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-003 Nov 20, 2008 ➤ Sign Up ➤ Sign Up
Depo Nf NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-002 Nov 20, 2008 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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