Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077809
Company: ANI PHARMS

• Safety Labeling Change Order Letter

Products on ANDA 077809

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CIPROFLOXACIN EXTENDED RELEASE	CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE	425.2MG;EQ 574.9MG BASE	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
CIPROFLOXACIN EXTENDED RELEASE	CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE	212.6MG;EQ 287.5MG BASE	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077809

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/30/2010	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
05/06/2019	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/24/2019	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/18/2018	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/27/2017	SUPPL-5	Labeling-Medication Guide, Labeling-Patient Package Insert		Label is not available on this site.
07/26/2016	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
11/19/2013	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
05/01/2012	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert, REMS-Modified		Label is not available on this site.
12/06/2011	SUPPL-1	Labeling-Package Insert		Label is not available on this site.