Assyro AI

Orange Book product · Generic (ANDA)

NALOXONE HYDROCHLORIDE

NALOXONE HYDROCHLORIDE

Generic (ANDA)ANDA 071681DISCN SMITH AND NEPHEW

At a glance

Nov 17, 1987

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 17, 1987

    39 yr 2 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

NALOXONE HYDROCHLORIDE

Strength

0.4MG/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

ANDA 071681

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of NALOXONE 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.