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Orange Book product · Generic (ANDA)

NALOXONE HYDROCHLORIDE

NALOXONE HYDROCHLORIDE

Generic (ANDA)ANDA 211951OTC PADAGIS ISRAEL
View NALOXONE HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Jun 21, 2022

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 21, 2022

    4 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

NALOXONE HYDROCHLORIDE

Strength

4MG/SPRAY

Dosage form

SPRAY, METERED

Route

NASAL

TE code

Not listed

Application

ANDA 211951

Product number

001

Marketing status

OTC

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.

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