Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077279
Company: TEVA PHARMS

Products on ANDA 077279

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077279

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/27/2008	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		Label is not available on this site.
11/08/2016	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 077279

CETIRIZINE HYDROCHLORIDE

SYRUP;ORAL; 5MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP;ORAL	Prescription	No	AA	090766	AMNEAL PHARMS
CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP;ORAL	Prescription	No	AA	090191	BAJAJ
CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP;ORAL	Prescription	No	AA	078488	BRECKENRIDGE
CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP;ORAL	Prescription	No	AA	078876	CHARTWELL MOLECULAR
CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP;ORAL	Prescription	No	AA	078398	PADAGIS US
CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP;ORAL	Prescription	No	AA	076601	TARO
CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP;ORAL	Prescription	No	AA	077279	TEVA PHARMS