Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213820
Company: RISING

Products on ANDA 213820

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 213820

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/27/2020	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213820Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/11/2022	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
11/12/2021	SUPPL-1	Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 213820

NITAZOXANIDE

TABLET;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALINIA	NITAZOXANIDE	500MG	TABLET;ORAL	Prescription	Yes	AB	021497	ROMARK
NITAZOXANIDE	NITAZOXANIDE	500MG	TABLET;ORAL	Prescription	No	AB	213820	RISING