Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

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 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
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
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 HIVES FEXOFENADINE HYDROCHLORIDE 30MG/5ML SUSPENSION;ORAL Over-the-counter No 203330 P AND L

CHILDREN'S ALLEGRA HIVES

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English