Assyro AI

Orange Book product · Generic (ANDA)

NEFAZODONE HYDROCHLORIDE

NEFAZODONE HYDROCHLORIDE

Generic (ANDA)ANDA 076129DISCN AUROBINDO PHARMA USA

At a glance

Sep 16, 2003

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 16, 2003

    23 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

NEFAZODONE HYDROCHLORIDE

Strength

100MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 076129

Product number

002

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of NEFAZODONE 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.