Details for New Drug Application (NDA): 078215
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NDA 078215 describes SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE, which is a drug marketed by West-ward Pharms Int 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 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 SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE 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 078215
| Tradename: | SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE |
| Applicant: | West-ward Pharms Int |
| Ingredient: | ferric oxyhydroxide |
| 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 | ferric oxyhydroxide | 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 | ferric oxyhydroxide | 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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