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TRAMADOL HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NOVITIUM PHARMA · Approved 2026-06-26

Drug application

FDA Application #

ANDA219647

Application type

Abbreviated New Drug Application (Generic)

Brand name

TRAMADOL HYDROCHLORIDE

Generic name

Tramadol Hydrochloride

Active ingredients

TRAMADOL HYDROCHLORIDE

Dosage form

SOLUTION

Route

ORAL

Marketing status

Prescription

Sponsor

NOVITIUM PHARMA

First approval

2026-06-26

Source

Authoritative

Drugs@FDA application overview

Machine

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