Assyro AI

Orange Book product · Generic (ANDA)

EXTENDED PHENYTOIN SODIUM

PHENYTOIN SODIUM

Generic (ANDA)ANDA 040435DISCN ANI PHARMS

At a glance

Jun 20, 2003

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 20, 2003

    23 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

PHENYTOIN SODIUM

Strength

100MG EXTENDED

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

ANDA 040435

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of PHENYTOIN SODIUM

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.