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Orange Book product · Generic (ANDA)

TRAMADOL HYDROCHLORIDE

TRAMADOL HYDROCHLORIDE

Generic (ANDA)ANDA 209404TE AB1RX MACLEODS PHARMS LTD
View TRAMADOL HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Jan 31, 2025

Approved

Generic (ANDA)

Application

AB1

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 31, 2025

    1 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

TRAMADOL HYDROCHLORIDE

Strength

100MG

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

AB1

Application

ANDA 209404

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of TRAMADOL HYDROCHLORIDE

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

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