Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210914
Company: HETERO LABS LTD III

Products on ANDA 210914

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVOCETIRIZINE HYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210914

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/01/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/23/2019	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 210914

LEVOCETIRIZINE HYDROCHLORIDE

SOLUTION;ORAL; 2.5MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	204599	CHARTWELL MOLECULAR
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	091263	PADAGIS US
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	202673	TARO
LEVOCETIRIZINE HYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	210914	HETERO LABS LTD III