Assyro AI

Orange Book product · Generic (ANDA)

LORAZEPAM

LORAZEPAM

Generic (ANDA)ANDA 074648DISCN ROXANE

At a glance

Mar 18, 1997

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 18, 1997

    29 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

LORAZEPAM

Strength

0.5MG/5ML

Dosage form

SOLUTION

Route

ORAL

TE code

Not listed

Application

ANDA 074648

Product number

001

Marketing status

DISCN

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.