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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021994
Company: SANDOZ

Products on NDA 021994

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021994

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
04/02/2020	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021994s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021994Orig1s013ltr.pdf
09/22/2017	SUPPL-12	Labeling-Package Insert, Labeling-Container/Carton Labels	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

Labels for NDA 021994

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/02/2020	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021994s013lbl.pdf
09/22/2017	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021994s012lbl.pdf
09/22/2017	SUPPL-12	Labeling-Container/Carton Labels	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

Therapeutic Equivalents for NDA 021994

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	SANDOZ
TRAVOPROST	TRAVOPROST	0.004%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	203431	APOTEX
TRAVOPROST	TRAVOPROST	0.004%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	207040	LUPIN LTD
TRAVOPROST	TRAVOPROST	0.004%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	203767	MICRO LABS
TRAVOPROST	TRAVOPROST	0.004%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	205050	MYLAN

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