Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065250
Company: ANI PHARMS

• Other Important Information from FDA

Products on ANDA 065250

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065250

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/25/2005	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-9	Labeling-Package Insert		Label is not available on this site.
08/17/2023	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
08/17/2023	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
08/17/2023	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
08/17/2023	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
08/17/2023	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
10/06/2008	SUPPL-2	Labeling		Label is not available on this site.