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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 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: 022304

Tradename:
NUCYNTA
Applicant:
Depomed Inc
Ingredient:
tapentadol hydrochloride
Patents:3
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 Stat Rx USA 16590-289 16590-289-60 60 TABLET, FILM COATED in 1 BOTTLE (16590-289-60)
NUCYNTA
tapentadol hydrochloride
TABLET;ORAL 022304 NDA Stat Rx USA 16590-863 16590-863-60 60 TABLET, FILM COATED in 1 BOTTLE (16590-863-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Nov 20, 2008TE:RLD:No
Patent:6,071,970Patent Expiration:Jun 6, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:RELIEF OF MODERATE TO SEVERE ACUTE PAIN
Patent:7,994,364Patent Expiration:Jun 27, 2025Product Flag?YSubstance Flag?YDelist Request?
Patented Use:RELIEF OF MODERATE TO SEVERE ACUTE PAIN
Patent:RE39593Patent Expiration:Aug 5, 2022Product Flag?YSubstance Flag?YDelist Request?
Patented Use:RELIEF OF MODERATE TO SEVERE ACUTE PAIN


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