Details for New Drug Application (NDA): 078215
NDA 078215 describes SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE, which is a drug marketed by Hikma and is included in one NDA. It is available from one supplier. Additional details are available on the SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE profile page.
The generic ingredient in SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE 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 SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE 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 078215
| Tradename: | SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE |
| Applicant: | Hikma |
| Ingredient: | sodium ferric gluconate complex |
| Patents: | 0 |
Pharmacology for NDA: 078215
| Mechanism of Action | Phosphate Chelating Activity |
Suppliers and Packaging for NDA: 078215
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE | sodium ferric gluconate complex | INJECTABLE;INJECTION | 078215 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9298 | 0143-9298-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9298-10) / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9298-01) |
| SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE | sodium ferric gluconate complex | INJECTABLE;INJECTION | 078215 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9570 | 0143-9570-10 | 10 VIAL in 1 CARTON (0143-9570-10) / 5 mL in 1 VIAL (0143-9570-01) |
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: | Mar 31, 2011 | TE: | AB | RLD: | No | ||||
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