Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076805
Company: TARO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LORATADINE LORATADINE 1MG/ML 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
08/20/2004 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/21/2011 SUPPL-25 Labeling-Container/Carton Labels

Label is not available on this site.

08/19/2014 SUPPL-20 Labeling

Label is not available on this site.

08/19/2014 SUPPL-19 Labeling

Label is not available on this site.

08/31/2009 SUPPL-17 Labeling

Label is not available on this site.

03/03/2008 SUPPL-4 Labeling

Label is not available on this site.

09/19/2007 SUPPL-2 Labeling

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; 1MG/ML
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CLARITIN LORATADINE 1MG/ML SYRUP;ORAL Over-the-counter Yes 020641 BAYER HEALTHCARE LLC
LORATADINE LORATADINE 1MG/ML SYRUP;ORAL Over-the-counter No 075728 PERRIGO
LORATADINE LORATADINE 1MG/ML SYRUP;ORAL Over-the-counter No 077421 SILARX
LORATADINE LORATADINE 1MG/ML SYRUP;ORAL Over-the-counter No 076805 TARO
LORATADINE LORATADINE 1MG/ML SYRUP;ORAL Over-the-counter No 201865 TARO PHARM
LORATADINE LORATADINE 1MG/ML SYRUP;ORAL Over-the-counter No 075505 TEVA
LORATADINE LORATADINE 1MG/ML SYRUP;ORAL Over-the-counter No 075815 WOCKHARDT

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