Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210033
Company: PERRIGO PHARMA INTL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LORATADINE LORATADINE 5MG TABLET, CHEWABLE;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
06/12/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

LORATADINE

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

TABLET, CHEWABLE;ORAL; 5MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CHILDREN'S CLARITIN LORATADINE 5MG TABLET, CHEWABLE;ORAL Over-the-counter Yes 021891 BAYER HEALTHCARE LLC
LORATADINE LORATADINE 5MG TABLET, CHEWABLE;ORAL Over-the-counter No 210033 PERRIGO PHARMA INTL
LORATADINE LORATADINE 5MG TABLET, CHEWABLE;ORAL Over-the-counter No 210088 SUN PHARM

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