Assyro AI

Orange Book product · Generic (ANDA)

NALMEFENE HYDROCHLORIDE

NALMEFENE HYDROCHLORIDE

Generic (ANDA)ANDA 216007RX CHENGDU SHUODE

At a glance

Nov 15, 2023

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 15, 2023

    2 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

NALMEFENE HYDROCHLORIDE

Strength

EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)

Dosage form

SOLUTION

Route

INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

TE code

Not listed

Application

ANDA 216007

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.