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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204599
Company: CHARTWELL MOLECULAR
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
05/15/2017 ORIG-1 Approval

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 204599 CHARTWELL MOLECULAR
LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION;ORAL Prescription No AA 091263 PADAGIS US
LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION;ORAL Prescription No AA 202673 TARO
LEVOCETIRIZINE HYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION;ORAL Prescription No AA 210914 HETERO LABS LTD III
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