Details for New Drug Application (NDA): 020955
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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 ferric oxyhydroxide. There are twenty drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the ferric oxyhydroxide profile page.
The generic ingredient in FERRLECIT is ferric oxyhydroxide. There are twenty drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the ferric oxyhydroxide profile page.
Summary for 020955
| Tradename: | FERRLECIT |
| Applicant: | Sanofi Aventis Us |
| Ingredient: | ferric oxyhydroxide |
| 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 | ferric oxyhydroxide | 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 | ferric oxyhydroxide | 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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