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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078870
Company: APOZEAL PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription AA No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/27/2009 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
04/19/2023 SUPPL-6 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.

CETIRIZINE HYDROCHLORIDE

SOLUTION;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 SOLUTION;ORAL Prescription No AA 090766 AMNEAL PHARMS
CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 078870 APOZEAL PHARMS
CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 090191 BAJAJ
CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 078488 BIONPHARMA
CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 078876 CHARTWELL MOLECULAR
CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 078398 PADAGIS US
CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 078412 PHARM ASSOC
CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 076601 TARO
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