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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215090
Company: SUNNY

Products on ANDA 215090

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PHYTONADIONE	PHYTONADIONE	10MG/ML	INJECTABLE;INJECTION	Prescription	AB1	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215090

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/09/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 215090

PHYTONADIONE

INJECTABLE;INJECTION; 10MG/ML
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PHYTONADIONE	PHYTONADIONE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AB1	219212	CAPLIN
PHYTONADIONE	PHYTONADIONE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AB1	207719	DR REDDYS
PHYTONADIONE	PHYTONADIONE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AB1	217386	GLAND
PHYTONADIONE	PHYTONADIONE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AB1	215090	SUNNY
VITAMIN K1	PHYTONADIONE	10MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AB1	087955	HOSPIRA

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