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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078398
Company: PADAGIS US
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 Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/17/2008 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-7 Labeling-Package Insert

Label is not available on this site.

11/08/2016 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

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
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