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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090766
Company: AMNEAL PHARMS
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/07/2009 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
03/12/2020 SUPPL-3 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

11/08/2016 SUPPL-2 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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