Details for New Drug Application (NDA): 020955
NDA 020955 describes FERRLECIT, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from one supplier. Additional details are available on the FERRLECIT profile page.
The generic ingredient in FERRLECIT is sodium ferric gluconate complex. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the sodium ferric gluconate complex profile page.
The generic ingredient in FERRLECIT is sodium ferric gluconate complex. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the sodium ferric gluconate complex profile page.
Summary for 020955
| Tradename: | FERRLECIT |
| Applicant: | Sanofi Aventis Us |
| Ingredient: | sodium ferric gluconate complex |
| Patents: | 0 |
Pharmacology for NDA: 020955
| Mechanism of Action | Phosphate Chelating Activity |
Suppliers and Packaging for NDA: 020955
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FERRLECIT | sodium ferric gluconate complex | INJECTABLE;INJECTION | 020955 | NDA | sanofi-aventis U.S. LLC | 0024-2792 | 0024-2792-10 | 10 VIAL, SINGLE-USE in 1 CARTON (0024-2792-10) / 5 mL in 1 VIAL, SINGLE-USE (0024-2792-01) |
| FERRLECIT | sodium ferric gluconate complex | INJECTABLE;INJECTION | 020955 | NDA | sanofi-aventis U.S. LLC | 0024-2794 | 0024-2794-10 | 10 VIAL, SINGLE-USE in 1 CARTON (0024-2794-10) / 5 mL in 1 VIAL, SINGLE-USE (0024-2794-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) | ||||
| Approval Date: | Feb 18, 1999 | TE: | AB | RLD: | Yes | ||||
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