Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213513
Company: HETERO LABS LTD III

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter None 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
04/29/2020 ORIG-1 Approval STANDARD

Label is not available on this site.

LEVOCETIRIZINE DIHYDROCHLORIDE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET;ORAL; 5MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 210375 DR REDDYS LABS LTD
LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 213513 HETERO LABS LTD III
LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 211551 MICRO LABS
LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter No 211983 PERRIGO R AND D
XYZAL ALLERGY 24HR LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET;ORAL Over-the-counter Yes 209089 SANOFI AVENTIS US

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