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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209429
Company: SOMERSET THERAPS LLC

Products on ANDA 209429

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 209429

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 209429

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

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