Assyro AI

Orange Book product · Generic (ANDA)

SODIUM PHENYLBUTYRATE

SODIUM PHENYLBUTYRATE

Generic (ANDA)ANDA 202819TE ABRX SIGMAPHARM LABS LLC

At a glance

Mar 22, 2013

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 22, 2013

    13 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

SODIUM PHENYLBUTYRATE

Strength

3GM/TEASPOONFUL

Dosage form

POWDER

Route

ORAL

TE code

AB

Application

ANDA 202819

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of SODIUM PHENYLBUTYRATE

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.