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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021498
Company: ROMARK

Products on NDA 021498

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALINIA	NITAZOXANIDE	100MG/5ML	FOR SUSPENSION;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021498

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/22/2002	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21498_Alinia_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21498ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-498_Alinia.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/19/2022	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021497s018,021498s019lbl.pdf
09/29/2014	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
07/25/2014	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
07/11/2016	SUPPL-4	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
06/16/2005	SUPPL-3	Efficacy-New Patient Population	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021498s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021498s003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021818s000_021498s003TOC.cfm
07/21/2004	SUPPL-2	Efficacy-New Patient Population		Label is not available on this site.
07/21/2004	SUPPL-1		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

Labels for NDA 021498

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/19/2022	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021497s018,021498s019lbl.pdf
07/11/2016	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021497s001,021498s004lbl.pdf
06/16/2005	SUPPL-3	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021498s003lbl.pdf
07/21/2004	SUPPL-1	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21497,21498s001lbl.pdf
11/22/2002	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21498_Alinia_lbl.pdf

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