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Last Updated: July 19, 2024

Details for New Drug Application (NDA): 202514


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NDA 202514 describes ZIOPTAN, which is a drug marketed by Thea Pharma and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ZIOPTAN profile page.

The generic ingredient in ZIOPTAN is tafluprost. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the tafluprost profile page.
Summary for 202514
Tradename:ZIOPTAN
Applicant:Thea Pharma
Ingredient:tafluprost
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 202514
Mechanism of ActionProstaglandin Receptor Agonists
Physiological EffectIncreased Prostaglandin Activity
Suppliers and Packaging for NDA: 202514
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZIOPTAN tafluprost SOLUTION/DROPS;OPHTHALMIC 202514 NDA AUTHORIZED GENERIC Prasco Laboratories 66993-429 66993-429-30 3 POUCH in 1 CARTON (66993-429-30) / 10 VIAL, SINGLE-USE in 1 POUCH (66993-429-81) / .3 mL in 1 VIAL, SINGLE-USE
ZIOPTAN tafluprost SOLUTION/DROPS;OPHTHALMIC 202514 NDA Thea Pharma Inc. 82584-609 82584-609-30 3 POUCH in 1 CARTON (82584-609-30) / 10 VIAL, SINGLE-USE in 1 POUCH (82584-609-01) / .3 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.0015%
Approval Date:Feb 10, 2012TE:ATRLD:Yes
Patent:⤷  Sign UpPatent Expiration:May 28, 2029Product Flag?YSubstance Flag?Delist Request?
Patented Use:REDUCTION OF ELEVATED INTRAOCULAR PRESSURE IN PATIENTS WITH OPEN ANGLE GLAUCOMA OR OCULAR HYPERTENSION
Patent:⤷  Sign UpPatent Expiration:May 28, 2029Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 202514

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Thea Pharma ZIOPTAN tafluprost SOLUTION/DROPS;OPHTHALMIC 202514-001 Feb 10, 2012 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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