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Details for New Drug Application (NDA): 016267

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NDA 016267 describes DESFERAL, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. Additional details are available on the DESFERAL profile page.

The generic ingredient in DESFERAL is deferoxamine mesylate. There are seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the deferoxamine mesylate profile page.

Summary for NDA: 016267

Tradename:
DESFERAL
Applicant:
Novartis
Ingredient:
deferoxamine mesylate
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 016267

Mechanism of ActionIron Chelating Activity

Suppliers and Packaging for NDA: 016267

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DESFERAL
deferoxamine mesylate
INJECTABLE;INJECTION 016267 NDA Novartis Pharmaceuticals Corporation 0078-0347 0078-0347-51 4 VIAL in 1 CARTON (0078-0347-51) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0078-0347-61)
DESFERAL
deferoxamine mesylate
INJECTABLE;INJECTION 016267 NDA Novartis Pharmaceuticals Corporation 0078-0467 0078-0467-91 4 VIAL in 1 CARTON (0078-0467-91) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0078-0467-61)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength500MG/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2GM/VIAL
Approval Date:May 25, 2000TE:APRLD:Yes

Expired Orange Book Patents for NDA: 016267

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
DESFERAL
deferoxamine mesylate
INJECTABLE;INJECTION016267-001Approved Prior to Jan 1, 19823,471,476► subscribe
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