Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020597
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
XALATAN LATANOPROST 0.005% 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
06/05/1996 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020597Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/10/2017 SUPPL-51 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020597s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020597Orig1s051ltr.pdf
04/03/2014 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

11/25/2014 SUPPL-48 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020597s045s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020597Orig1s045,s048ltr.pdf
03/13/2013 SUPPL-46 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020597s046lbl.pdf
11/25/2014 SUPPL-45 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020597s045s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020597Orig1s045,s048ltr.pdf
03/13/2012 SUPPL-44 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020597s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020597s044ltr.pdf
07/29/2010 SUPPL-39 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

08/31/2010 SUPPL-36 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020597s035s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020597s035,s036ltr.pdf
08/31/2010 SUPPL-35 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020597s035s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020597s035,s036ltr.pdf
07/14/2003 SUPPL-29 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20597scs029,slr028ltr.pdf
07/14/2003 SUPPL-28 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20597scs029,slr028ltr.pdf
11/15/2002 SUPPL-26 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020597Orig1s026Approv.pdf
08/26/2002 SUPPL-25 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20597s25lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20597scp025ltr.pdf
06/21/2002 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/26/2001 SUPPL-23 Manufacturing (CMC)-Control Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20597s23lbl.pdf
05/14/2001 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/23/2001 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

08/08/2001 SUPPL-19 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20597s19lbl.pdf
08/25/2000 SUPPL-18 Labeling

Label is not available on this site.

12/11/2000 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

11/09/2000 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/26/2000 SUPPL-14 Labeling

Label is not available on this site.

06/02/2000 SUPPL-13 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020597Orig1s013Approv.pdf
10/08/1999 SUPPL-12 Labeling

Label is not available on this site.

01/24/2000 SUPPL-11 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020597Orig1s011Approv.pdf
12/20/2002 SUPPL-10 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20597SE1-010_Xalatan_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20597se1-010ltr.pdf
07/16/1999 SUPPL-8 Labeling

Label is not available on this site.

03/22/1999 SUPPL-7 Labeling

Label is not available on this site.

11/01/1998 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/31/1998 SUPPL-5 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020597Orig1s005Approv.pdf
12/09/1998 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

06/23/1998 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/10/2017 SUPPL-51 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020597s051lbl.pdf
11/25/2014 SUPPL-48 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020597s045s048lbl.pdf
11/25/2014 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020597s045s048lbl.pdf
03/13/2013 SUPPL-46 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020597s046lbl.pdf
03/13/2012 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020597s044lbl.pdf
08/31/2010 SUPPL-36 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020597s035s036lbl.pdf
08/31/2010 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020597s035s036lbl.pdf
12/20/2002 SUPPL-10 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20597SE1-010_Xalatan_lbl.pdf
08/26/2002 SUPPL-25 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20597s25lbl.pdf
11/26/2001 SUPPL-23 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20597s23lbl.pdf
08/08/2001 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20597s19lbl.pdf

XALATAN

SOLUTION/DROPS;OPHTHALMIC; 0.005%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LATANOPROST LATANOPROST 0.005% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 090887 AKORN
LATANOPROST LATANOPROST 0.005% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 200925 AMRING PHARMS
LATANOPROST LATANOPROST 0.005% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 201006 BAUSCH AND LOMB
LATANOPROST LATANOPROST 0.005% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 202077 DR REDDYS LABS LTD
LATANOPROST LATANOPROST 0.005% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 202442 FDC LTD
LATANOPROST LATANOPROST 0.005% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 201786 MYLAN
LATANOPROST LATANOPROST 0.005% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 091449 SANDOZ INC
XALATAN LATANOPROST 0.005% SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 020597 PHARMACIA AND UPJOHN

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