Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091264
Company: HETERO LABS LTD III

Products on ANDA 091264

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091264

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/29/2012	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
07/11/2025	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
06/28/2019	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
06/28/2019	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
09/18/2017	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
11/24/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
01/30/2013	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
11/29/2012	SUPPL-1	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 091264

LEVOCETIRIZINE DIHYDROCHLORIDE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	090392	DR REDDYS LABS LTD
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	090385	GLENMARK PHARMS LTD
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	091264	HETERO LABS LTD III
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	205564	MACLEODS PHARMS LTD
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	202046	MICRO LABS LTD INDIA
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	203646	SCIEGEN PHARMS
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	090362	SUN PHARM
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	090229	SYNTHON BV
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	090199	TEVA PHARMS