Assyro AI

Orange Book product · Generic (ANDA)

NALMEFENE HYDROCHLORIDE

NALMEFENE HYDROCHLORIDE

Generic (ANDA)ANDA 212955TE APRX KNOA PHARMA

At a glance

Feb 08, 2022

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 08, 2022

    4 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

NALMEFENE HYDROCHLORIDE

Strength

EQ 2MG BASE/2ML (EQ 1MG BASE/ML)

Dosage form

SOLUTION

Route

INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

TE code

AP

Application

ANDA 212955

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

Active-ingredient family

View full family

Generic (ANDA) of NALMEFENE 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.