FDA Orange Book · active-ingredient family
Sodium ferric gluconate complex
Sodium ferric gluconate complex is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:FERRLECIT · NDA 020955
1
Brand (NDA)
1
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FERRLECITRLD | SANOFI AVENTIS US | NDA 020955 | AB | Feb 18, 1999 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE | HIKMA | ANDA 078215 | AB | Mar 31, 2011 |
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.
Sodium ferric gluconate complex — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
