Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210088
Company: SUN PHARM
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
04/16/2018 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210088Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/05/2020 SUPPL-7 Labeling-Package Insert, Labeling-Container/Carton Labels

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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