Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019992
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CILOXAN CIPROFLOXACIN HYDROCHLORIDE EQ 0.3% BASE SOLUTION/DROPS;OPHTHALMIC Prescription AT Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/31/1990 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/21/2017 SUPPL-26 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019992s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019992Orig1s026ltr.pdf
02/07/2006 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019992s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019992s020ltr.pdf
08/20/2004 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19992s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19992s019ltr.pdf
03/13/2002 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

09/14/2001 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/16/2001 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

02/18/2000 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/17/1999 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

02/05/1999 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/11/1999 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

10/14/1998 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

11/09/1999 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/15/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/01/1995 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

11/01/1995 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

10/27/1994 SUPPL-4 Efficacy-New Patient Population

Label is not available on this site.

01/22/1993 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

10/27/1993 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/12/1992 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/21/2017 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019992s026lbl.pdf
03/21/2017 SUPPL-26 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019992s026lbl.pdf
02/07/2006 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019992s020lbl.pdf
08/20/2004 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19992s019lbl.pdf

CILOXAN

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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