Assyro AI

Orange Book product · Generic (ANDA)

DROPERIDOL

DROPERIDOL

Generic (ANDA)ANDA 072123TE APRX AM REGENT

At a glance

Oct 24, 1988

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 24, 1988

    38 yr 2 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

DROPERIDOL

Strength

2.5MG/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

AP

Application

ANDA 072123

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

Active-ingredient family

View full family

Generic (ANDA) of DROPERIDOL

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.