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Last Updated: April 23, 2025

Details for New Drug Application (NDA): 080515

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NDA 080515 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, Nanjing King-friend, Norvium Bioscience, 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-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-three suppliers are listed for this compound. Additional details are available on the cyanocobalamin profile page.

Summary for 080515

Tradename:	CYANOCOBALAMIN
Applicant:	West-ward Pharms Int
Ingredient:	cyanocobalamin
Patents:	0

Pharmacology for NDA: 080515

Suppliers and Packaging for NDA: 080515

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CYANOCOBALAMIN	cyanocobalamin	INJECTABLE;INJECTION	080515	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9619	0143-9619-01	30 mL in 1 VIAL, MULTI-DOSE (0143-9619-01)
CYANOCOBALAMIN	cyanocobalamin	INJECTABLE;INJECTION	080515	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9619	0143-9619-10	10 VIAL, MULTI-DOSE in 1 BOX (0143-9619-10) / 30 mL in 1 VIAL, MULTI-DOSE (0143-9619-01)

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1MG/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AP	RLD:	No

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