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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216601
Company: AMNEAL

Products on ANDA 216601

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PHYTONADIONE	PHYTONADIONE	1MG/0.5ML	INJECTABLE;INJECTION	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216601

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/04/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216601

PHYTONADIONE

INJECTABLE;INJECTION; 1MG/0.5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PHYTONADIONE	PHYTONADIONE	1MG/0.5ML	INJECTABLE;INJECTION	Prescription	No	AB	216444	ALEMBIC
PHYTONADIONE	PHYTONADIONE	1MG/0.5ML	INJECTABLE;INJECTION	Prescription	No	AB	216601	AMNEAL
PHYTONADIONE	PHYTONADIONE	1MG/0.5ML	INJECTABLE;INJECTION	Prescription	No	AB	214966	CIPLA
PHYTONADIONE	PHYTONADIONE	1MG/0.5ML	INJECTABLE;INJECTION	Prescription	Yes	AB	083722	INTL MEDICATION

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