Assyro AI

Orange Book product · Generic (ANDA)

SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE

SODIUM FERRIC GLUCONATE COMPLEX

Generic (ANDA)ANDA 078215TE ABRX HIKMA

At a glance

Mar 31, 2011

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 31, 2011

    15 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

SODIUM FERRIC GLUCONATE COMPLEX

Strength

EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)

Dosage form

INJECTABLE

Route

INJECTION

TE code

AB

Application

ANDA 078215

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 FERRIC GLUCONATE COMPLEX

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.