Assyro AI

Orange Book product · Generic (ANDA)

LORAZEPAM INTENSOL

LORAZEPAM

Generic (ANDA)ANDA 072755TE AARX HIKMA

At a glance

Jun 28, 1991

Approved

Generic (ANDA)

Application

AA

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 28, 1991

    35 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

LORAZEPAM

Strength

2MG/ML

Dosage form

CONCENTRATE

Route

ORAL

TE code

AA

Application

ANDA 072755

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

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.