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Orange Book product · Generic (ANDA)

NORTRIPTYLINE HYDROCHLORIDE

NORTRIPTYLINE HYDROCHLORIDE

Generic (ANDA)ANDA 217731TE AARX RUBICON RESEARCH

At a glance

Aug 15, 2023

Approved

Generic (ANDA)

Application

AA

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 15, 2023

    2 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

NORTRIPTYLINE HYDROCHLORIDE

Strength

EQ 10MG BASE/5ML

Dosage form

SOLUTION

Route

ORAL

TE code

AA

Application

ANDA 217731

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of NORTRIPTYLINE 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.