Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075565
Company: APOTEX INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LORATADINE LORATADINE 1MG/ML SYRUP;ORAL Discontinued None No No
LORATADINE LORATADINE 5MG/5ML SYRUP; 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
10/05/2004 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.

SYRUP; ORAL; 5MG/5ML
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
LORATADINE LORATADINE 5MG/5ML SYRUP; ORAL Over-the-counter No 075565 APOTEX INC

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