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Iron dextranis the generic ingredient in four branded drugs marketed by Am Regent, Allergan, Sanofi Aventis Us, and New River, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.
There are eighty-two drug master file entries for iron dextran. Five suppliers are listed for this compound.
Recent Clinical Trials for IRON DEXTRAN
Identify potential brand extensions & 505(b)(2) entrants
|Hospital for Special Surgery, New York||Phase 1|
|Orthopedic Research and Education Foundation||Phase 1|
|West China Hospital||N/A|
Pharmacology for IRON DEXTRAN
|Drug Class||Parenteral Iron Replacement |
|Mechanism of Action||Phosphate Chelating Activity |
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|Allergan||INFED||iron dextran||INJECTABLE;INJECTION||017441-001||Approved Prior to Jan 1, 1982||BP||RX||Yes||Yes||Start Trial||Start Trial||Start Trial|
|New River||PROFERDEX||iron dextran||INJECTABLE;INJECTION||017807-001||Approved Prior to Jan 1, 1982||DISCN||No||No||Start Trial||Start Trial||Start Trial|
|Sanofi Aventis Us||IRON DEXTRAN||iron dextran||INJECTABLE;INJECTION||010787-002||Approved Prior to Jan 1, 1982||DISCN||No||No||Start Trial||Start Trial||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||Patent No.||Patent Expiration|
|Am Regent||DEXFERRUM||iron dextran||INJECTABLE;INJECTION||040024-001||Feb 23, 1996||Start Trial||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>Patent No.||>Patent Expiration|
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