Assyro AI

Orange Book product · Brand (NDA)

FERRLECIT

SODIUM FERRIC GLUCONATE COMPLEX

Brand (NDA)NDA 020955TE ABRX SANOFI AVENTIS US
View SODIUM FERRIC GLUCONATE COMPLEX familyOpen on FDA Orange Book

At a glance

Feb 18, 1999

Approved

Brand (NDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 18, 1999

    27 yr 9 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

NDA 020955

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

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.

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