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Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 080737

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NDA 080737 describes CYANOCOBALAMIN, which is a drug marketed by Abraxis Pharm, Akorn, Dell Labs, Fresenius Kabi Usa, Luitpold, Lyphomed, Mylan Institutional, Mylan Labs Ltd, Sanofi Aventis Us, Solopak, Somerset Theraps Llc, Warner Chilcott, Watson Labs, West-ward Pharms Int, Wyeth Ayerst, West Ward, and Mallinckrodt, and is included in nineteen NDAs. It is available from eleven suppliers. Additional details are available on the CYANOCOBALAMIN profile page.

The generic ingredient in CYANOCOBALAMIN is cyanocobalamin; cyanocobalamin co-57; intrinsic factor. There are nine drug master file entries for this compound. Additional details are available on the cyanocobalamin; cyanocobalamin co-57; intrinsic factor profile page.
Summary for 080737
Tradename:CYANOCOBALAMIN
Applicant:Luitpold
Ingredient:cyanocobalamin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 080737
Ingredient-typeVitamin B 12
Suppliers and Packaging for NDA: 080737
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYANOCOBALAMIN cyanocobalamin INJECTABLE;INJECTION 080737 ANDA American Regent, Inc. 0517-0031 0517-0031-25 25 VIAL, SINGLE-USE in 1 TRAY (0517-0031-25) > 1 mL in 1 VIAL, SINGLE-USE
CYANOCOBALAMIN cyanocobalamin INJECTABLE;INJECTION 080737 ANDA American Regent, Inc. 0517-0032 0517-0032-25 25 VIAL, MULTI-DOSE in 1 TRAY (0517-0032-25) > 10 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Queensland Health
QuintilesIMS
Express Scripts
Mallinckrodt
Dow
Merck
Healthtrust
Medtronic
Argus Health

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