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Last Updated: July 5, 2020

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Details for New Drug Application (NDA): 021994


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NDA 021994 describes TRAVATAN Z, which is a drug marketed by Novartis and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TRAVATAN Z profile page.

The generic ingredient in TRAVATAN Z is travoprost. There are fifteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the travoprost profile page.
Summary for 021994
Tradename:TRAVATAN Z
Applicant:Novartis
Ingredient:travoprost
Patents:3
Formulation / Manufacturing:see details
Pharmacology for NDA: 021994
Medical Subject Heading (MeSH) Categories for 021994
Suppliers and Packaging for NDA: 021994
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRAVATAN Z travoprost SOLUTION/DROPS;OPHTHALMIC 021994 NDA Alcon Laboratories, Inc 0065-0260 0065-0260-02 1 BOTTLE in 1 CARTON (0065-0260-02) > 2.5 mL in 1 BOTTLE
TRAVATAN Z travoprost SOLUTION/DROPS;OPHTHALMIC 021994 NDA Alcon Laboratories, Inc 0065-0260 0065-0260-05 1 BOTTLE in 1 CARTON (0065-0260-05) > 5 mL in 1 BOTTLE
Paragraph IV (Patent) Challenges for 021994
Tradename Dosage Ingredient NDA Submissiondate
TRAVATAN Z SOLUTION/DROPS;OPHTHALMIC travoprost 021994 2009-02-19

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.004%
Approval Date:Sep 21, 2006TE:ATRLD:Yes
Patent:  Start TrialPatent Expiration:Oct 13, 2029Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Sep 20, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Sep 20, 2027Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021994

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis TRAVATAN Z travoprost SOLUTION/DROPS;OPHTHALMIC 021994-001 Sep 21, 2006   Start Trial   Start Trial
Novartis TRAVATAN Z travoprost SOLUTION/DROPS;OPHTHALMIC 021994-001 Sep 21, 2006   Start Trial   Start Trial
Novartis TRAVATAN Z travoprost SOLUTION/DROPS;OPHTHALMIC 021994-001 Sep 21, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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