Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078166
Company: ANCHEN PHARMS
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 Prescription AB No Yes
CIPROFLOXACIN EXTENDED RELEASE CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE 212.6MG;EQ 287.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription None No Yes
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 Labeling-Container/Carton Labels, REMS-Proposal

Label is not available on this site.

06/19/2009 SUPPL-1 Labeling

Label is not available on this site.

CIPROFLOXACIN EXTENDED RELEASE

TABLET, EXTENDED RELEASE;ORAL; 425.2MG;EQ 574.9MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CIPROFLOXACIN EXTENDED RELEASE CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE 425.2MG;EQ 574.9MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078166 ANCHEN PHARMS
CIPROFLOXACIN EXTENDED RELEASE CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE 425.2MG;EQ 574.9MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 077701 DR REDDYS LABS LTD

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