Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078355
Company: BELCHER PHARMS

Products on ANDA 078355

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 078355

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/19/2012	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
05/01/2023	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
05/12/2014	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078355

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