Assyro AI

Orange Book product · Generic (ANDA)

NALOXONE HYDROCHLORIDE

NALOXONE HYDROCHLORIDE

Generic (ANDA)ANDA 072076TE APRX INTL MEDICATION

At a glance

Mar 24, 1988

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 24, 1988

    38 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

NALOXONE HYDROCHLORIDE

Strength

1MG/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

AP

Application

ANDA 072076

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

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.