ALINIA از شرکت ROMARK

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

ALINIA از شرکت ROMARK

New Drug Application (NDA): 021498

Company: ROMARK

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusTE CodeRLDRS
ALINIANITAZOXANIDE100MG/5MLFOR SUSPENSION;ORALPrescription

None

YesYes
Original Approvals or Tentative Approvals
Action DateSubmissionAction TypeSubmission ClassificationReview Priority; Orphan StatusLetters, Reviews, Labels, Patient Package InsertNotesUrl
11/22/2002ORIG-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 DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package InsertNoteUrl
09/29/2014SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/25/2014SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/11/2016SUPPL-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

06/16/2005SUPPL-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

07/21/2004SUPPL-2 Efficacy-New Patient Population

Label is not available on this site.

07/21/2004SUPPL-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

Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels,
Patient Package Insert
NoteUrl
07/11/2016SUPPL-4

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021497s001,021498s004lbl.pdf
06/16/2005SUPPL-3

Efficacy-New Patient Population

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021498s003lbl.pdf
07/21/2004SUPPL-1

Supplement

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21497,21498s001lbl.pdf
11/22/2002ORIG-1 Approval

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21498_Alinia_lbl.pdf
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