Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075990
Company: ACTAVIS LABS FL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LORATADINE LORATADINE 10MG TABLET, ORALLY DISINTEGRATING;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
11/03/2003 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.

TABLET, ORALLY DISINTEGRATING;ORAL; 10MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ALAVERT LORATADINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Over-the-counter No 021375 PFIZER
CLARITIN HIVES RELIEF REDITAB LORATADINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Over-the-counter Yes 020704 BAYER HEALTHCARE LLC
CLARITIN REDITABS LORATADINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Over-the-counter Yes 020704 BAYER HEALTHCARE LLC
LORATADINE LORATADINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Over-the-counter No 075990 ACTAVIS LABS FL INC
LORATADINE LORATADINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Over-the-counter No 076011 PERRIGO PHARMA INTL
LORATADINE LORATADINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Over-the-counter No 075822 PFIZER
LORATADINE REDIDOSE LORATADINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Over-the-counter No 077153 SUN PHARM INDS LTD

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