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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 two suppliers. There is one patent 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. Two suppliers are listed for this compound. Additional details are available on the tafluprost profile page.

Summary for NDA: 202514

Tradename:
ZIOPTAN
Applicant:
Oak Pharms Inc
Ingredient:
tafluprost
Patents:1
Formulation / Manufacturing:see details

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 Merck Sharp & Dohme Corp. 0006-3931 0006-3931-30 3 POUCH in 1 CARTON (0006-3931-30) > 10 AMPULE in 1 POUCH (0006-3931-10) > .3 mL in 1 AMPULE
ZIOPTAN
tafluprost
SOLUTION/DROPS;OPHTHALMIC 202514 NDA Merck Sharp & Dohme Corp. 0006-3931 0006-3931-36 1 POUCH in 1 CARTON (0006-3931-36) > 10 AMPULE in 1 POUCH > .3 mL in 1 AMPULE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.0015%
Approval Date:Feb 10, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 10, 2017
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:5,886,035Patent Expiration:Dec 18, 2022Product Flag?YSubstance Flag?YDelist Request?
Patented Use:REDUCTION OF ELEVATED INTRAOCULAR PRESSURE IN PATEINTS WITH OPEN ANGLE GLAUCOMA OR OCULAR HYPERTENSION


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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