CETIRIZINE HYDROCHLORIDE از شرکت TEVA PHARMS

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

CETIRIZINE HYDROCHLORIDE از شرکت TEVA PHARMS

Abbreviated New Drug Application (ANDA): 077279

Company: TEVA 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
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.

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 078488 BRECKENRIDGE
CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Prescription No AA 078876 LANNETT CO INC
CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Prescription No AA 090191 MLV
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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