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Orange Book product · Generic (ANDA)

TRAMADOL HYDROCHLORIDE

TRAMADOL HYDROCHLORIDE

Generic (ANDA)ANDA 075986DISCN MYLAN
View TRAMADOL HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Jun 21, 2002

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 21, 2002

    24 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

TRAMADOL HYDROCHLORIDE

Strength

50MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 075986

Product number

001

Marketing status

DISCN

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.

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