Assyro AI

Orange Book product · Generic (ANDA)

ORPHENADRINE CITRATE

ORPHENADRINE CITRATE

Generic (ANDA)ANDA 091158TE ABRX UNICHEM

At a glance

Jul 27, 2012

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 27, 2012

    14 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ORPHENADRINE CITRATE

Strength

100MG

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

AB

Application

ANDA 091158

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of ORPHENADRINE CITRATE

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.