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Last Updated: December 22, 2024

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 Pharma Ltd, Luitpold, Lyphomed, Mankind Pharma, Mylan Institutional, Mylan Labs Ltd, 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 NDAs. It is available from twenty-two 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-four 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:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1MG/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AP	RLD:	Yes

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