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): 201373

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/5ML SUSPENSION;ORAL Over-the-counter

None

Yes Yes
CHILDREN’S ALLEGRA HIVES FEXOFENADINE HYDROCHLORIDE 30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SUSPENSION;ORAL Discontinued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
01/24/2011 ORIG-1 Approval

Type 8 – Partial Rx to OTC Switch

STANDARD

Label (PDF)

Letter (PDF)

Review

Summary Review (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201373Orig1s000lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201373s000ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201373_allegra_toc.cfm
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201373Orig1s000SumR.pdf

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/17/2021 SUPPL-11 Manufacturing (CMC)-Formulation

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/201373Orig1s011lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/201373Orig1s011ltr.pdf

11/02/2020 SUPPL-10 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201373Orig1s010lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/201373Orig1s010ltr.pdf

06/15/2016 SUPPL-6 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201373Orig1s006lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201373Orig1s006ltr.pdf

04/28/2013 SUPPL-5 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201373Orig1s005lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201373Orig1s005ltr.pdf

08/23/2012 SUPPL-4 Labeling-Container/Carton Labels

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201373Orig1s004ltr.pdf

02/23/2012 SUPPL-2 Labeling-Package Insert

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201373s002ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/17/2021 SUPPL-11

Manufacturing (CMC)-Formulation

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/201373Orig1s011lbl.pdf
11/02/2020 SUPPL-10

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201373Orig1s010lbl.pdf
06/15/2016 SUPPL-6

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201373Orig1s006lbl.pdf
04/28/2013 SUPPL-5

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201373Orig1s005lbl.pdf
01/24/2011 ORIG-1 Approval

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201373Orig1s000lbl.pdf

CHILDREN’S ALLEGRA ALLERGY

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SUSPENSION;ORAL; 30MG/5ML
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CHILDREN’S ALLEGRA ALLERGY FEXOFENADINE HYDROCHLORIDE 30MG/5ML SUSPENSION;ORAL Over-the-counter Yes 201373 SANOFI AVENTIS US
CHILDREN’S FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 30MG/5ML SUSPENSION;ORAL Over-the-counter No 203330 P AND L
CHILDREN’S FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 30MG/5ML SUSPENSION;ORAL Over-the-counter No 208123 TARO
CHILDREN’S FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 30MG/5ML SUSPENSION;ORAL Over-the-counter No 203330 P AND L
CHILDREN’S FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 30MG/5ML SUSPENSION;ORAL Over-the-counter No 208123 TARO

CHILDREN’S ALLEGRA HIVES

There are no other OTC drugs with the same Active Ingredient, Strength and Dosage Form/Route.

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