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Orange Book product · Generic (ANDA)

AMANTADINE HYDROCHLORIDE

AMANTADINE HYDROCHLORIDE

Generic (ANDA)ANDA 073115DISCN TEVA PHARMS
View AMANTADINE HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Aug 23, 1991

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 23, 1991

    35 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

AMANTADINE HYDROCHLORIDE

Strength

50MG/5ML

Dosage form

SYRUP

Route

ORAL

TE code

Not listed

Application

ANDA 073115

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of AMANTADINE 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

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