CHILDREN’S ALLEGRA ALLERGY از شرکت SANOFI AVENTIS US

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

CHILDREN’S ALLEGRA ALLERGY از شرکت SANOFI AVENTIS US

New Drug Application (NDA): 021909

Company: SANOFI AVENTIS US

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHILDREN’S ALLEGRA ALLERGY FEXOFENADINE HYDROCHLORIDE 30MG TABLET, ORALLY DISINTEGRATING;ORAL Discontinued

None

Yes No
CHILDREN’S ALLEGRA HIVES FEXOFENADINE HYDROCHLORIDE 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, ORALLY DISINTEGRATING;ORAL Discontinued

None

Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/26/2007 ORIG-1 Approval

Type 3 – New Dosage Form

STANDARD

Label (PDF)

Letter (PDF)

Review

https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021909lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021909s000_ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021909_allegra_toc.cfm

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/03/2020 SUPPL-15 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021909Orig1s015lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021909Orig1s015ltr.pdf

08/05/2016 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/01/2016 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

06/10/2016 SUPPL-10 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021909Orig1s010lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021909Orig1s010ltr.pdf

12/09/2013 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/31/2014 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/28/2013 SUPPL-7 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021909Orig1s007lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021909Orig1s007ltr.pdf

08/23/2012 SUPPL-6 Labeling-Package Insert

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021909Orig1s006ltr.pdf

01/24/2011 SUPPL-3 Efficacy-Rx To OTC Switch

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021909Orig1s003lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021909s003ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/03/2020 SUPPL-15

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021909Orig1s015lbl.pdf
06/10/2016 SUPPL-10

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021909Orig1s010lbl.pdf
04/28/2013 SUPPL-7

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021909Orig1s007lbl.pdf
01/24/2011 SUPPL-3

Efficacy-Rx To OTC Switch

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021909Orig1s003lbl.pdf
07/26/2007 ORIG-1 Approval

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021909lbl.pdf
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