Details for New Drug Application (NDA): 214655

NDA 214655 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-three 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 214655

Tradename:	CYANOCOBALAMIN
Applicant:	Zydus Pharms
Ingredient:	cyanocobalamin
Patents:	0

Pharmacology for NDA: 214655

Suppliers and Packaging for NDA: 214655

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CYANOCOBALAMIN	cyanocobalamin	INJECTABLE;INJECTION	214655	ANDA	Zydus Pharmaceuticals USA Inc.	70710-1663	70710-1663-7	25 VIAL, MULTI-DOSE in 1 CARTON (70710-1663-7) / 1 mL in 1 VIAL, MULTI-DOSE (70710-1663-1)
CYANOCOBALAMIN	cyanocobalamin	INJECTABLE;INJECTION	214655	ANDA	Zydus Pharmaceuticals USA Inc.	70710-1664	70710-1664-6	10 VIAL, MULTI-DOSE in 1 CARTON (70710-1664-6) / 10 mL in 1 VIAL, MULTI-DOSE (70710-1664-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1MG/ML
Approval Date:	Apr 15, 2022	TE:	AP	RLD:	No

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