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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203330
Company: P AND L

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 30MG/5ML SUSPENSION;ORAL Over-the-counter None No No
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 30MG/5ML SUSPENSION;ORAL Over-the-counter None No Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/18/2014 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/03/2020 SUPPL-5 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

CHILDREN'S FEXOFENADINE HYDROCHLORIDE 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 FEXOFENADINE HYDROCHLORIDE HIVES

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
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