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DEFEROXAMINE MESYLATE

ANDA

DEFEROXAMINE MESYLATE | A076019 | HOSPIRA INC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: DESFERAL(TE code: AP)

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Ben Venue Laboratories, Inc. - ANDA Suitability Petition FDA-2007-P-0298 · 5 docket documents Ben Venue Laboratories, Inc. filed this petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act seeking a determination that an additional 1 gram dosage of Deferoxamine Mesylate for Injection, USP is suitable for submission as an Abbreviated New Drug Application (ANDA), with	Suitability	2008-07-15	Withdrawn	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

API Supply Chain3 active DMFs4 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

TAPI NL BVDEFEROXAMINE MESYLATE

DMF 122411996

EXCELLA GMBH AND CO KGDEFEROXAMINE MESYLATE

DMF 184592005

EXCELLA GMBH AND CO KGDEFEROXAMINE MESYLATE USP

DMF 254212012

PHARMACIA AND UPJOHNInactiveDEFEROXAMINE MESYLATE

DMF 100411993

MYTHEN SPAInactiveDEFEROXAMINE MESYLATE

DMF 166532003

MYTHEN SPAInactiveDEFEROXAMINE MESYLATE NT

DMF 190522005

NAVINTA LLCInactiveDEFEROXAMINE MESYLATE USP

DMF 202532007

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 19, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 500MG/VIAL

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Mar 17, 2004

No patent or exclusivity listings for this strength.

#002 — 2GM/VIAL

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Mar 17, 2004