Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078357
Company: ORCHID HLTHCARE
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
02/19/2010 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/78357Ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/18/2019 SUPPL-5 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

02/11/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

12/20/2013 SUPPL-1 Labeling-Patient Package Insert, 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 MERCK SHARP DOHME
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 ORCHID HLTHCARE
DESLORATADINE DESLORATADINE 5MG TABLET;ORAL Prescription No AB 078361 PERRIGO
DESLORATADINE DESLORATADINE 5MG TABLET;ORAL Prescription No AB 078364 SANDOZ
DESLORATADINE DESLORATADINE 5MG TABLET;ORAL Prescription No AB 078359 SUN PHARM INDS

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