Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203027
Company: APOTEX

Products on ANDA 203027

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203027

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/13/2015	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
11/05/2020	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
11/05/2020	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
11/05/2020	SUPPL-9	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
11/05/2020	SUPPL-8	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
12/27/2017	SUPPL-6	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
12/27/2017	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
12/27/2017	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/27/2017	SUPPL-3	Labeling-Package Insert		Label is not available on this site.