Assyro AI

Orange Book product · Generic (ANDA)

BETAXOLOL HYDROCHLORIDE

BETAXOLOL HYDROCHLORIDE

Generic (ANDA)ANDA 075630TE ATRX EUROFARMA

At a glance

Apr 12, 2001

Approved

Generic (ANDA)

Application

AT

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 12, 2001

    25 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

BETAXOLOL HYDROCHLORIDE

Strength

EQ 0.5% BASE

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

TE code

AT

Application

ANDA 075630

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of BETAXOLOL HYDROCHLORIDE

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.