Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213466
Company: AUROBINDO PHARMA LTD

Products on ANDA 213466

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213466

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/23/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

FEXOFENADINE HYDROCHLORIDE

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