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Orange Book product · Generic (ANDA)

ROPIVACAINE HYDROCHLORIDE

ROPIVACAINE HYDROCHLORIDE

Generic (ANDA)ANDA 204636TE APRX RISING

At a glance

Mar 16, 2018

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 16, 2018

    8 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ROPIVACAINE HYDROCHLORIDE

Strength

200MG/100ML (2MG/ML)

Dosage form

SOLUTION

Route

INJECTION

TE code

AP

Application

ANDA 204636

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of ROPIVACAINE HYDROCHLORIDE

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.