Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078166
Company: ANCHEN PHARMS

Products on ANDA 078166

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 078166

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/27/2007	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
05/03/2019	SUPPL-14	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/18/2018	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
04/26/2019	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/26/2016	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
07/18/2016	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
07/18/2016	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
08/14/2013	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/14/2012	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
03/17/2010	SUPPL-2	REMS-Proposal, Labeling-Container/Carton Labels		Label is not available on this site.
06/19/2009	SUPPL-1	Labeling		Label is not available on this site.