An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 209255
Company: VITRUVIAS THERAP

Products on ANDA 209255

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CYANOCOBALAMIN	CYANOCOBALAMIN	1MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209255

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/18/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 209255

CYANOCOBALAMIN

INJECTABLE;INJECTION; 1MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CYANOCOBALAMIN	CYANOCOBALAMIN	1MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	080737	AM REGENT
CYANOCOBALAMIN	CYANOCOBALAMIN	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	213874	EUGIA PHARMA
CYANOCOBALAMIN	CYANOCOBALAMIN	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	214390	GLAND PHARMA LTD
CYANOCOBALAMIN	CYANOCOBALAMIN	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	204829	MYLAN LABS LTD
CYANOCOBALAMIN	CYANOCOBALAMIN	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	215107	SAGENT PHARMS INC
CYANOCOBALAMIN	CYANOCOBALAMIN	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	212915	SANDOZ
CYANOCOBALAMIN	CYANOCOBALAMIN	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	215417	SOLA PHARMS
CYANOCOBALAMIN	CYANOCOBALAMIN	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	206503	SOMERSET THERAPS LLC
CYANOCOBALAMIN	CYANOCOBALAMIN	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	209429	SOMERSET THERAPS LLC
CYANOCOBALAMIN	CYANOCOBALAMIN	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	209255	VITRUVIAS THERAP
CYANOCOBALAMIN	CYANOCOBALAMIN	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	080515	WEST-WARD PHARMS INT
CYANOCOBALAMIN	CYANOCOBALAMIN	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	214655	ZYDUS PHARMS
DODEX	CYANOCOBALAMIN	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	083022	ACCORD HLTHCARE
VIBISONE	CYANOCOBALAMIN	1MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	080557	FRESENIUS KABI USA

Top