Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021994
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRAVATAN Z TRAVOPROST 0.004% 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
09/21/2006 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021994lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021994s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021994s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/22/2017 SUPPL-12 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021994s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021994Orig1s012ltr.pdf
03/11/2016 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/07/2011 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021994s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021994s006ltr.pdf
08/31/2010 SUPPL-1 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021994s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021994s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/22/2017 SUPPL-12 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021994s012lbl.pdf
09/22/2017 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021994s012lbl.pdf
09/07/2011 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021994s006lbl.pdf
08/31/2010 SUPPL-1 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021994s001lbl.pdf
09/21/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021994lbl.pdf

TRAVATAN Z

SOLUTION/DROPS;OPHTHALMIC; 0.004%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TRAVATAN Z TRAVOPROST 0.004% SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 021994 NOVARTIS
TRAVOPROST TRAVOPROST 0.004% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 203431 APOTEX
TRAVOPROST TRAVOPROST 0.004% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 205050 MYLAN

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