Assyro AI

Orange Book product · Generic (ANDA)

BEPOTASTINE BESILATE

BEPOTASTINE BESILATE

Generic (ANDA)ANDA 206220TE ATRX MYLAN

At a glance

Mar 18, 2019

Approved

Generic (ANDA)

Application

AT

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 18, 2019

    7 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

BEPOTASTINE BESILATE

Strength

1.5%

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

TE code

AT

Application

ANDA 206220

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of BEPOTASTINE BESILATE

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.