Details for New Drug Application (NDA): 212559
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NDA 212559 describes IRON SUCROSE, which is a drug marketed by Intl Medication Sys, Mylan Labs Ltd, and Sandoz, and is included in three NDAs. It is available from three suppliers. Additional details are available on the IRON SUCROSE profile page.
The generic ingredient in IRON SUCROSE is iron sucrose. There are eighty-two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the iron sucrose profile page.
The generic ingredient in IRON SUCROSE is iron sucrose. There are eighty-two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the iron sucrose profile page.
Summary for 212559
| Tradename: | IRON SUCROSE |
| Applicant: | Mylan Labs Ltd |
| Ingredient: | iron sucrose |
| Patents: | 0 |
Pharmacology for NDA: 212559
| Mechanism of Action | Phosphate Chelating Activity |
Suppliers and Packaging for NDA: 212559
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IRON SUCROSE | iron sucrose | INJECTABLE;INTRAVENOUS | 212559 | ANDA | Mylan Institutional LLC | 67457-638 | 67457-638-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-638-10) / 5 mL in 1 VIAL, SINGLE-DOSE |
| IRON SUCROSE | iron sucrose | INJECTABLE;INTRAVENOUS | 212559 | ANDA | Mylan Institutional LLC | 67457-638 | 67457-638-25 | 25 VIAL, SINGLE-DOSE in 1 CARTON (67457-638-25) / 5 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) | ||||
| Approval Date: | Aug 8, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 100MG IRON/5ML (EQ 20MG IRON/ML) | ||||
| Approval Date: | Aug 8, 2025 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Feb 7, 2026 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 200MG IRON/10ML (EQ 20MG IRON/ML) | ||||
| Approval Date: | Aug 8, 2025 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Feb 7, 2026 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
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