Orange Book product
FERRLECIT EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)
Orange Book NDA 020955 · SANOFI AVENTIS US LLC · Prescription
Key facts
| Proprietary name | FERRLECIT |
|---|---|
| Active ingredients | SODIUM FERRIC GLUCONATE COMPLEX |
| Strength | EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) |
| Dosage form | INJECTABLE |
| Route | INJECTION |
| Application | NDA020955 |
| Applicant holder | SANOFI AVENTIS US LLC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | Yes |
| Reference standard (RS) | Yes |
| Approval date | Feb 18, 1999 |
At a glance
- 1–9 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- Yes Reference listed drug
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Orange Book products
The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.