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. Five 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

Pharmacology for NDA: 202514

Mechanism of Action	Prostaglandin Receptor Agonists
Physiological Effect	Increased 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:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.0015%
Approval Date:	Feb 10, 2012	TE:	AT	RLD:	Yes
Patent:	⤷ Subscribe	Patent Expiration:	May 28, 2029	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	REDUCTION OF ELEVATED INTRAOCULAR PRESSURE IN PATIENTS WITH OPEN ANGLE GLAUCOMA OR OCULAR HYPERTENSION
Patent:	⤷ Subscribe	Patent Expiration:	May 28, 2029	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 202514

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

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