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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 080737


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NDA 080737 describes CYANOCOBALAMIN, which is a drug marketed by Abraxis Pharm, Am Regent, Dell Labs, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland, Luitpold, Lyphomed, Mankind Pharma, Meitheal, Mylan Institutional, Pharmobedient, Sagent Pharms Inc, Sandoz, Sanofi Aventis Us, Sola Pharms, Solopak, Somerset Theraps Llc, Vitruvias Therap, Warner Chilcott, Watson Labs, West-ward Pharms Int, Wyeth Ayerst, Xiromed, Zydus Pharms, Lupin, Padagis Israel, and West Ward, and is included in thirty-one NDAs. It is available from twenty-four suppliers. Additional details are available on the CYANOCOBALAMIN profile page.

The generic ingredient in CYANOCOBALAMIN is cyanocobalamin. There are nine drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the cyanocobalamin profile page.
Summary for 080737
Tradename:CYANOCOBALAMIN
Applicant:Am Regent
Ingredient:cyanocobalamin
Patents:0
Pharmacology for NDA: 080737
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, MULTI-DOSE in 1 TRAY (0517-0031-25) / 1 mL in 1 VIAL, MULTI-DOSE (0517-0031-01)
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 (0517-0032-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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