U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 201373
Company: CHATTEM SANOFI
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ALLEGRA HIVES FEXOFENADINE HYDROCHLORIDE 30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUSPENSION;ORAL Discontinued None Yes No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
12/27/2022 SUPPL-13 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201373Orig1s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/201373Orig1s013ltr.pdf
12/20/2022 SUPPL-12 Manufacturing (CMC)-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201373Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/201373Orig1s012ltr.pdf
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
12/27/2022 SUPPL-13 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201373Orig1s013lbl.pdf
12/20/2022 SUPPL-12 Manufacturing (CMC)-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201373Orig1s012lbl.pdf
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 CHATTEM SANOFI
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
FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 30MG/5ML SUSPENSION;ORAL Over-the-counter No 213466 AUROBINDO PHARMA LTD

CHILDREN'S ALLEGRA HIVES

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

Back to Top