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TAPENTADOL HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HUMANWELL · Approved 2026-01-27

Drug application

FDA Application #

ANDA214378

Application type

Abbreviated New Drug Application (Generic)

Brand name

TAPENTADOL HYDROCHLORIDE

Generic name

TAPENTADOL HYDROCHLORIDE

Active ingredients

TAPENTADOL HYDROCHLORIDE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

HUMANWELL

Manufacturer

EPIC PHARMA LLC

First approval

2026-01-27

Source

Authoritative

Drugs@FDA application overview

Machine

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