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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021497
Company: ROMARK

Products on NDA 021497

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALINIA	NITAZOXANIDE	500MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021497

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/21/2004	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21497,21498s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21497,21498s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-497_21-498s001_Alinia.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/19/2022	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021497s018,021498s019lbl.pdf
12/16/2021	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021497s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021497Orig1s017ltr.pdf
03/03/2015	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
12/05/2012	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
07/11/2016	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021497s001,021498s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021497Orig1s001,021498Orig1s004ltr.pdf

Labels for NDA 021497

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/19/2022	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021497s018,021498s019lbl.pdf
12/16/2021	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021497s017lbl.pdf
07/11/2016	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021497s001,021498s004lbl.pdf
07/21/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21497,21498s001lbl.pdf

Therapeutic Equivalents for NDA 021497

ALINIA

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

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