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Orange Book product · Generic (ANDA)

SODIUM PHENYLBUTYRATE

SODIUM PHENYLBUTYRATE

Generic (ANDA)ANDA 090910DISCN ALVOGEN

At a glance

Nov 18, 2011

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 18, 2011

    14 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

SODIUM PHENYLBUTYRATE

Strength

500MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 090910

Product number

001

Marketing status

DISCN

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.