Assyro AI

Orange Book product · Generic (ANDA)

CEVIMELINE HYDROCHLORIDE

CEVIMELINE HYDROCHLORIDE

Generic (ANDA)ANDA 091591TE ABRX HIKMA

At a glance

Jul 08, 2013

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 08, 2013

    13 yr 2 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CEVIMELINE HYDROCHLORIDE

Strength

30MG

Dosage form

CAPSULE

Route

ORAL

TE code

AB

Application

ANDA 091591

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of CEVIMELINE 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.