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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021257
Company: ALCON PHARMS LTD

Products on NDA 021257

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TRAVATAN	TRAVOPROST	0.004% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS;OPHTHALMIC	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021257

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.

Labels for NDA 021257

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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