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Orange Book product · Generic (ANDA)

ROPIVACAINE HYDROCHLORIDE

ROPIVACAINE HYDROCHLORIDE

Generic (ANDA)ANDA 205612TE APRX EUGIA PHARMA

At a glance

Jul 13, 2016

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 13, 2016

    10 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ROPIVACAINE HYDROCHLORIDE

Strength

40MG/20ML (2MG/ML)

Dosage form

SOLUTION

Route

INJECTION

TE code

AP

Application

ANDA 205612

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.