Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075685
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET;ORAL Discontinued None No No
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Discontinued None No No
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET;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
06/09/2004 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75685ta.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/17/2015 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

11/17/2015 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

03/05/2012 SUPPL-11 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/08/2011 SUPPL-10 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert, REMS-Modified

Label is not available on this site.

05/10/2010 SUPPL-8 Labeling-Container/Carton Labels

Label is not available on this site.

07/22/2009 SUPPL-7 Labeling, REMS-Proposal

Label is not available on this site.

01/29/2009 SUPPL-6 Labeling

Label is not available on this site.

04/14/2005 SUPPL-1 Labeling

Label is not available on this site.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English