Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065195
Company: NORVIUM BIOSCIENCE

• Other Important Information from FDA

Products on ANDA 065195

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLARITHROMYCIN	CLARITHROMYCIN	250MG	TABLET;ORAL	Discontinued	None	No	No
CLARITHROMYCIN	CLARITHROMYCIN	500MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065195

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/11/2005	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
08/16/2023	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
12/11/2015	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
12/11/2012	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
07/18/2012	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
04/27/2010	SUPPL-9	Labeling-Container/Carton Labels		Label is not available on this site.
12/11/2015	SUPPL-7	Labeling		Label is not available on this site.
05/24/2007	SUPPL-3	Labeling		Label is not available on this site.