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Last Updated: April 15, 2026

Details for New Drug Application (NDA): 214378


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NDA 214378 describes TAPENTADOL HYDROCHLORIDE, which is a drug marketed by Novitium Pharma, Hikma, and Humanwell, and is included in three NDAs. It is available from one supplier. Additional details are available on the TAPENTADOL HYDROCHLORIDE profile page.

The generic ingredient in TAPENTADOL HYDROCHLORIDE is tapentadol hydrochloride. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the tapentadol hydrochloride profile page.
Summary for 214378
Tradename:TAPENTADOL HYDROCHLORIDE
Applicant:Humanwell
Ingredient:tapentadol hydrochloride
Patents:0
Pharmacology for NDA: 214378
Mechanism of ActionOpioid Agonists
Suppliers and Packaging for NDA: 214378
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TAPENTADOL HYDROCHLORIDE tapentadol hydrochloride TABLET;ORAL 214378 ANDA EPIC PHARMA LLC 42806-626 42806-626-01 100 TABLET, FILM COATED in 1 BOTTLE (42806-626-01)
TAPENTADOL HYDROCHLORIDE tapentadol hydrochloride TABLET;ORAL 214378 ANDA EPIC PHARMA LLC 42806-627 42806-627-01 100 TABLET, FILM COATED in 1 BOTTLE (42806-627-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Jan 27, 2026TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 75MG BASE
Approval Date:Jan 27, 2026TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Jan 27, 2026TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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