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Last Updated: April 23, 2025

Details for New Drug Application (NDA): 214390

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NDA 214390 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 214390

Tradename:	CYANOCOBALAMIN
Applicant:	Gland Pharma Ltd
Ingredient:	cyanocobalamin
Patents:	0

Pharmacology for NDA: 214390

Suppliers and Packaging for NDA: 214390

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CYANOCOBALAMIN	cyanocobalamin	INJECTABLE;INJECTION	214390	ANDA	Gland Pharma Limited	68083-449	68083-449-25	25 VIAL, MULTI-DOSE in 1 CARTON (68083-449-25) / 1 mL in 1 VIAL, MULTI-DOSE
CYANOCOBALAMIN	cyanocobalamin	INJECTABLE;INJECTION	214390	ANDA	Gland Pharma Limited	68083-561	68083-561-25	25 VIAL, MULTI-DOSE in 1 CARTON (68083-561-25) / 10 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1MG/ML
Approval Date:	Sep 24, 2020	TE:	AP	RLD:	No

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