Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209373
Company: AMNEAL PHARMS CO

Products on ANDA 209373

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 209373

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/11/2018	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209373Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/25/2024	SUPPL-8	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 209373

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 LIFESCIENCES