Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078712
Company: FOSUN PHARMA
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
12/11/2007 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-6 Labeling-Package Insert

Label is not available on this site.

10/18/2018 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

04/24/2019 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

07/26/2016 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

07/26/2016 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

12/04/2013 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

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