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Orange Book product · Generic (ANDA)

BENZTROPINE MESYLATE

BENZTROPINE MESYLATE

Generic (ANDA)ANDA 204713TE AARX NUVO PHARM

At a glance

Apr 14, 2015

Approved

Generic (ANDA)

Application

AA

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 14, 2015

    11 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

BENZTROPINE MESYLATE

Strength

0.5MG

Dosage form

TABLET

Route

ORAL

TE code

AA

Application

ANDA 204713

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.