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Orange Book product · Generic (ANDA)

NALBUPHINE HYDROCHLORIDE

NALBUPHINE HYDROCHLORIDE

Generic (ANDA)ANDA 216049TE APRX SOMERSET THERAPS LLC
View NALBUPHINE HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Sep 19, 2024

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 19, 2024

    1 yr 9 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

NALBUPHINE HYDROCHLORIDE

Strength

100MG/10ML (10MG/ML)

Dosage form

SOLUTION

Route

INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

TE code

AP

Application

ANDA 216049

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of NALBUPHINE 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

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