Assyro AI

Orange Book product · Generic (ANDA)

SULFADIAZINE

SULFADIAZINE

Generic (ANDA)ANDA 040091RX EPIC PHARMA LLC

At a glance

Jul 29, 1994

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 29, 1994

    32 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

SULFADIAZINE

Strength

500MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 040091

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

Active-ingredient family

View full family

Generic (ANDA) of SULFADIAZINE

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.