Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065178
Company: HIKMA

• Other Important Information from FDA

Products on ANDA 065178

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065178

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/25/2004	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-17	Labeling-Package Insert		Label is not available on this site.
12/17/2019	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
12/17/2019	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
12/17/2019	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
02/13/2015	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
02/13/2015	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
02/13/2015	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
12/11/2012	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
07/18/2012	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
07/18/2012	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
06/20/2007	SUPPL-6	Labeling		Label is not available on this site.
03/08/2007	SUPPL-5	Labeling		Label is not available on this site.
04/20/2005	SUPPL-1	Labeling		Label is not available on this site.