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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078365
Company: DR REDDYS LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DESLORATADINE DESLORATADINE 5MG TABLET;ORAL Prescription AB 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
03/08/2011 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
11/22/2011 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

DESLORATADINE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLARINEX DESLORATADINE 5MG TABLET;ORAL Prescription Yes AB 021165 ORGANON
DESLORATADINE DESLORATADINE 5MG TABLET;ORAL Prescription No AB 078355 BELCHER PHARMS
DESLORATADINE DESLORATADINE 5MG TABLET;ORAL Prescription No AB 078365 DR REDDYS LABS LTD
DESLORATADINE DESLORATADINE 5MG TABLET;ORAL Prescription No AB 078352 LUPIN PHARMS
DESLORATADINE DESLORATADINE 5MG TABLET;ORAL Prescription No AB 078357 ORBION PHARMS
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