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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218701
Company: ANNORA PHARMA

Products on ANDA 218701

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NITAZOXANIDE	NITAZOXANIDE	500MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218701

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/15/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218701

NITAZOXANIDE

TABLET;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NITAZOXANIDE	NITAZOXANIDE	500MG	TABLET;ORAL	Prescription	No	AB	214844	ANI PHARMS
NITAZOXANIDE	NITAZOXANIDE	500MG	TABLET;ORAL	Prescription	No	AB	218701	ANNORA PHARMA
NITAZOXANIDE	NITAZOXANIDE	500MG	TABLET;ORAL	Prescription	No	AB	213820	RISING

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