Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076134
Company: SUN PHARM INDS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LORATADINE LORATADINE 10MG TABLET;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
08/18/2003 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/76134.ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076134Orig1Approv.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/24/2009 SUPPL-19 Labeling

Label is not available on this site.

03/23/2007 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

04/16/2007 SUPPL-8 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.

TABLET;ORAL; 10MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CLARITIN LORATADINE 10MG TABLET;ORAL Over-the-counter Yes 019658 BAYER HEALTHCARE LLC
CLARITIN HIVES RELIEF LORATADINE 10MG TABLET;ORAL Over-the-counter Yes 019658 BAYER HEALTHCARE LLC
LORATADINE LORATADINE 10MG TABLET;ORAL Over-the-counter No 076471 APOTEX INC
LORATADINE LORATADINE 10MG TABLET;ORAL Over-the-counter No 075790 MYLAN
LORATADINE LORATADINE 10MG TABLET;ORAL Over-the-counter No 076154 MYLAN
LORATADINE LORATADINE 10MG TABLET;ORAL Over-the-counter No 078447 MYLAN
LORATADINE LORATADINE 10MG TABLET;ORAL Over-the-counter No 076301 PERRIGO
LORATADINE LORATADINE 10MG TABLET;ORAL Over-the-counter No 075209 SANDOZ
LORATADINE LORATADINE 10MG TABLET;ORAL Over-the-counter No 076134 SUN PHARM INDS LTD

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