Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077568
Company: FDC LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 0.3% BASE SOLUTION/DROPS;OPHTHALMIC Prescription AT 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
06/30/2008 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
03/16/2015 SUPPL-6 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

CIPROFLOXACIN HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC; EQ 0.3% BASE
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CILOXAN CIPROFLOXACIN HYDROCHLORIDE EQ 0.3% BASE SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 019992 NOVARTIS
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 0.3% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 076555 AKORN INC
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 0.3% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 204613 ALTAIRE PHARMS INC
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 0.3% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 077568 FDC LTD
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 0.3% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 077689 RISING
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 0.3% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 076754 TELIGENT
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 0.3% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 076673 WATSON LABS INC

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