Assyro AI

Orange Book product · Generic (ANDA)

LORAZEPAM

LORAZEPAM

Generic (ANDA)ANDA 076045TE ABRX SUN PHARM INDS LTD

At a glance

Aug 29, 2001

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 29, 2001

    25 yr 2 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

LORAZEPAM

Strength

0.5MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 076045

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of LORAZEPAM

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.