Details for New Drug Application (NDA): 212572
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NDA 212572 describes FERRIC CARBOXYMALTOSE, which is a drug marketed by Mylan and Mylan Labs Ltd and is included in three NDAs. It is available from one supplier. Additional details are available on the FERRIC CARBOXYMALTOSE profile page.
The generic ingredient in FERRIC CARBOXYMALTOSE is ferric carboxymaltose. There are twenty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the ferric carboxymaltose profile page.
The generic ingredient in FERRIC CARBOXYMALTOSE is ferric carboxymaltose. There are twenty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the ferric carboxymaltose profile page.
Summary for 212572
| Tradename: | FERRIC CARBOXYMALTOSE |
| Applicant: | Mylan Labs Ltd |
| Ingredient: | ferric carboxymaltose |
| Patents: | 0 |
Pharmacology for NDA: 212572
| Mechanism of Action | Phosphate Chelating Activity |
Suppliers and Packaging for NDA: 212572
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FERRIC CARBOXYMALTOSE | ferric carboxymaltose | SOLUTION;INTRAVENOUS | 212572 | ANDA | Mylan Institutional LLC | 67457-797 | 67457-797-15 | 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-797-15) / 15 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 750MG IRON/15ML (50MG IRON/ML) | ||||
| Approval Date: | Jun 25, 2026 | TE: | AP | RLD: | No | ||||
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