Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021257
Company: ALCON PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRAVATAN TRAVOPROST 0.004% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION/DROPS;OPHTHALMIC Discontinued None Yes No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
03/16/2001 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21257lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21257_Travatan_approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21257_Travatan.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/07/2011 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021257s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021257s025ltr.pdf
08/31/2010 SUPPL-18 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021257s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021257s018ltr.pdf
01/23/2006 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021257s014s015LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021257s014s015ltr.pdf
01/23/2006 SUPPL-14 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021257s014s015LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021257s014s015ltr.pdf
02/20/2004 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21257scp012,slr013_travitran_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21257scp012,slr013ltr.pdf
02/20/2004 SUPPL-12 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21257scp012,slr013_travitran_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21257scp012,slr013ltr.pdf
05/15/2003 SUPPL-10 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21257scp010travatan_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21257scp010ltr.pdf
02/13/2003 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021257s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21257se8-006,21257slr008,009ltr.pdf
02/13/2003 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021257s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21257se8-006,21257slr008,009ltr.pdf
12/04/2002 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/13/2003 SUPPL-6 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021257s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21257se8-006,21257slr008,009ltr.pdf
12/04/2002 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/2002 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/25/2002 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/07/2011 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021257s025lbl.pdf
08/31/2010 SUPPL-18 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021257s018lbl.pdf
01/23/2006 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021257s014s015LBL.pdf
01/23/2006 SUPPL-14 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021257s014s015LBL.pdf
02/20/2004 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21257scp012,slr013_travitran_lbl.pdf
02/20/2004 SUPPL-12 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21257scp012,slr013_travitran_lbl.pdf
05/15/2003 SUPPL-10 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21257scp010travatan_lbl.pdf
02/13/2003 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021257s006lbl.pdf
02/13/2003 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021257s006lbl.pdf
02/13/2003 SUPPL-6 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021257s006lbl.pdf
03/16/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21257lbl.pdf

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