Assyro AI

Orange Book product · Generic (ANDA)

BENZTROPINE MESYLATE

BENZTROPINE MESYLATE

Generic (ANDA)ANDA 090287TE APRX HIKMA FARMACEUTICA

At a glance

Aug 31, 2009

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 31, 2009

    17 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

BENZTROPINE MESYLATE

Strength

1MG/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

AP

Application

ANDA 090287

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

Active-ingredient family

View full family

Generic (ANDA) of BENZTROPINE MESYLATE

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.