Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078357
Company: ORBION PHARMS

Products on ANDA 078357

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DESLORATADINE	DESLORATADINE	5MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078357

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-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078357

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