Assyro AI

Orange Book product · Generic (ANDA)

ROCURONIUM BROMIDE

ROCURONIUM BROMIDE

Generic (ANDA)ANDA 205656TE APRX GLAND

At a glance

Apr 04, 2018

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 04, 2018

    8 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ROCURONIUM BROMIDE

Strength

50MG/5ML (10MG/ML)

Dosage form

INJECTABLE

Route

INJECTION

TE code

AP

Application

ANDA 205656

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

Active-ingredient family

View full family

Generic (ANDA) of ROCURONIUM BROMIDE

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.