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Generated: November 15, 2018

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Details for New Drug Application (NDA): 202514

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NDA 202514 describes ZIOPTAN, which is a drug marketed by Oak Pharms Inc and is included in one NDA. It is available from one supplier. 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. One supplier is listed for this compound. Additional details are available on the tafluprost profile page.
Summary for 202514
Tradename:ZIOPTAN
Applicant:Oak Pharms Inc
Ingredient:tafluprost
Patents:2
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 202514
Generic Entry Date for 202514*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION/DROPS;OPHTHALMIC

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 202514
Ingredient-typeProstaglandins
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 Akorn, Inc. 17478-609 17478-609-10 1 POUCH in 1 CARTON (17478-609-10) > 10 VIAL, SINGLE-USE in 1 POUCH (17478-609-01) > .3 mL in 1 VIAL, SINGLE-USE
ZIOPTAN tafluprost SOLUTION/DROPS;OPHTHALMIC 202514 NDA Akorn, Inc. 17478-609 17478-609-30 3 POUCH in 1 CARTON (17478-609-30) > 10 VIAL, SINGLE-USE in 1 POUCH (17478-609-01) > .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:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Dec 18, 2022Product Flag?YSubstance Flag?YDelist Request?
Patented Use:REDUCTION OF ELEVATED INTRAOCULAR PRESSURE IN PATIENTS WITH OPEN ANGLE GLAUCOMA OR OCULAR HYPERTENSION
Patent:➤ Try a Free TrialPatent Expiration:May 28, 2029Product Flag?YSubstance Flag?Delist Request?

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