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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202538
Company: BIONPHARMA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LORATADINE LORATADINE 10MG CAPSULE;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
12/21/2018 ORIG-1 Approval

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.

CAPSULE;ORAL; 10MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CLARITIN LORATADINE 10MG CAPSULE;ORAL Over-the-counter Yes 021952 BAYER HEALTHCARE LLC
LORATADINE LORATADINE 10MG CAPSULE;ORAL Over-the-counter No 202538 BIONPHARMA INC
LORATADINE LORATADINE 10MG CAPSULE;ORAL Over-the-counter No 206214 MARKSANS PHARMA
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