Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078367
Company: REDDYS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DESLORATADINE DESLORATADINE 2.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No
DESLORATADINE DESLORATADINE 5MG TABLET, ORALLY DISINTEGRATING;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
07/12/2010 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078367s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/22/2019 SUPPL-5 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

02/11/2015 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

11/18/2011 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

DESLORATADINE

TABLET, ORALLY DISINTEGRATING;ORAL; 2.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLARINEX DESLORATADINE 2.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021312 MERCK SHARP DOHME
DESLORATADINE DESLORATADINE 2.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078367 REDDYS

TABLET, ORALLY DISINTEGRATING;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, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021312 MERCK SHARP DOHME
DESLORATADINE DESLORATADINE 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078367 REDDYS

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