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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075747
Company: SUN PHARM INDS LTD

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 750MG 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)
Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75747TA.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/75747ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/18/2013 SUPPL-15 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
11/18/2013 SUPPL-14 Labeling-Package Insert

Label is not available on this site.
11/18/2013 SUPPL-13 Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.
11/18/2013 SUPPL-12 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
07/22/2009 SUPPL-11 REMS-Proposal, Labeling

Label is not available on this site.
12/04/2008 SUPPL-10 Labeling

Label is not available on this site.
06/18/2008 SUPPL-9 Labeling

Label is not available on this site.
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