Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211443
Company: APOTEX

Products on ANDA 211443

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET;ORAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211443

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/21/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

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

LEVOCETIRIZINE DIHYDROCHLORIDE

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

TABLET;ORAL; 5MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET;ORAL	Over-the-counter	No	211443	APOTEX
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET;ORAL	Over-the-counter	No	210375	DR REDDYS
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET;ORAL	Over-the-counter	No	213513	HETERO LABS LTD III
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET;ORAL	Over-the-counter	No	211551	MICRO LABS
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET;ORAL	Over-the-counter	No	211983	PERRIGO R AND D
XYZAL ALLERGY 24HR	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET;ORAL	Over-the-counter	Yes	209089	CHATTEM SANOFI