Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077417
Company: ANI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CIPROFLOXACIN EXTENDED RELEASE CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE 212.6MG;EQ 287.5MG BASE TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
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-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.

11/22/2011 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

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