Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202673
Company: TARO PHARM INDS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/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
07/26/2013 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
11/13/2015 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

LEVOCETIRIZINE DIHYDROCHLORIDE

SOLUTION;ORAL; 2.5MG/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION;ORAL Prescription No AA 202915 APOTEX INC
LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION;ORAL Prescription No AA 091263 L PERRIGO CO
LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION;ORAL Prescription No AA 204599 LANNETT CO INC
LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION;ORAL Prescription No AA 202673 TARO PHARM INDS LTD
LEVOCETIRIZINE HYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION;ORAL Prescription No AA 210914 HETERO LABS LTD III
XYZAL LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION;ORAL Prescription Yes AA 022157 SANOFI AVENTIS US

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