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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213329
Company: SCIEGEN PHARMS INC

Products on ANDA 213329

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PHYTONADIONE	PHYTONADIONE	5MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213329

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/28/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 213329

PHYTONADIONE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PHYTONADIONE	PHYTONADIONE	5MG	TABLET;ORAL	Prescription	No	AB	213336	AGNITIO
PHYTONADIONE	PHYTONADIONE	5MG	TABLET;ORAL	Prescription	No	AB	209373	AMNEAL PHARMS CO
PHYTONADIONE	PHYTONADIONE	5MG	TABLET;ORAL	Prescription	No	AB	213329	SCIEGEN PHARMS INC
PHYTONADIONE	PHYTONADIONE	5MG	TABLET;ORAL	Prescription	No	AB	210189	ZYDUS

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