Assyro AI

Orange Book product · Generic (ANDA)

GALANTAMINE HYDROBROMIDE

GALANTAMINE HYDROBROMIDE

Generic (ANDA)ANDA 078185RX HIKMA

At a glance

Jan 30, 2009

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 30, 2009

    17 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

GALANTAMINE HYDROBROMIDE

Strength

4MG/ML

Dosage form

SOLUTION

Route

ORAL

TE code

Not listed

Application

ANDA 078185

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

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.