Details for New Drug Application (NDA): 076019
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NDA 076019 describes DEFEROXAMINE MESYLATE, which is a drug marketed by Dr Reddys, Fresenius Kabi Usa, Gland, Hikma, and Hospira, 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. Six 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. Six suppliers are listed for this compound. Additional details are available on the deferoxamine mesylate profile page.
Summary for 076019
| Tradename: | DEFEROXAMINE MESYLATE |
| Applicant: | Hospira |
| Ingredient: | deferoxamine mesylate |
| Patents: | 0 |
Pharmacology for NDA: 076019
| Mechanism of Action | Iron Chelating Activity |
Medical Subject Heading (MeSH) Categories for 076019
Suppliers and Packaging for NDA: 076019
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEFEROXAMINE MESYLATE | deferoxamine mesylate | INJECTABLE;INJECTION | 076019 | ANDA | Hospira, Inc. | 0409-2337 | 0409-2337-25 | 4 VIAL, SINGLE-USE in 1 CARTON (0409-2337-25) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (0409-2337-15) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 500MG/VIAL | ||||
| Approval Date: | Mar 17, 2004 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2GM/VIAL | ||||
| Approval Date: | Mar 17, 2004 | TE: | AP | RLD: | No | ||||
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