Details for New Drug Application (NDA): 078718
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NDA 078718 describes DEFEROXAMINE MESYLATE, which is a drug marketed by Dr Reddys, Fresenius Kabi Usa, Gland Pharma Ltd, Hospira, and West-ward Pharms Int, and is included in five NDAs. It is available from four suppliers. Additional details are available on the DEFEROXAMINE MESYLATE profile page.
The generic ingredient in DEFEROXAMINE MESYLATE is deferoxamine mesylate. There are seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the deferoxamine mesylate profile page.
The generic ingredient in DEFEROXAMINE MESYLATE is deferoxamine mesylate. There are seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the deferoxamine mesylate profile page.
Summary for 078718
| Tradename: | DEFEROXAMINE MESYLATE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | deferoxamine mesylate |
| Patents: | 0 |
Pharmacology for NDA: 078718
| Mechanism of Action | Iron Chelating Activity |
Medical Subject Heading (MeSH) Categories for 078718
Suppliers and Packaging for NDA: 078718
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEFEROXAMINE MESYLATE | deferoxamine mesylate | INJECTABLE;INJECTION | 078718 | ANDA | Fresenius Kabi USA, LLC | 63323-597 | 63323-597-10 | 1 VIAL in 1 BOX (63323-597-10) / 5.3 mL in 1 VIAL |
| DEFEROXAMINE MESYLATE | deferoxamine mesylate | INJECTABLE;INJECTION | 078718 | ANDA | Fresenius Kabi USA, LLC | 63323-599 | 63323-599-30 | 1 VIAL in 1 BOX (63323-599-30) / 21.1 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 500MG/VIAL | ||||
| Approval Date: | Sep 15, 2009 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2GM/VIAL | ||||
| Approval Date: | Sep 15, 2009 | TE: | AP | RLD: | No | ||||
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