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Orange Book product · Generic (ANDA)

GALANTAMINE HYDROBROMIDE

GALANTAMINE HYDROBROMIDE

Generic (ANDA)ANDA 078898TE ABRX ZYDUS PHARMS USA INC

At a glance

Feb 17, 2011

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 17, 2011

    15 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

GALANTAMINE HYDROBROMIDE

Strength

EQ 4MG BASE

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 078898

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of GALANTAMINE HYDROBROMIDE

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.