Assyro AI

Orange Book product · Generic (ANDA)

AMANTADINE HYDROCHLORIDE

AMANTADINE HYDROCHLORIDE

Generic (ANDA)ANDA 074028TE AARX CHARTWELL RX
View AMANTADINE HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Jun 28, 1993

Approved

Generic (ANDA)

Application

AA

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 28, 1993

    33 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

AMANTADINE HYDROCHLORIDE

Strength

50MG/5ML

Dosage form

SYRUP

Route

ORAL

TE code

AA

Application

ANDA 074028

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

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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