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Federal Trade Commission
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Generated: November 12, 2018

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Details for New Drug Application (NDA): 205098

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NDA 205098 describes VARITHENA, which is a drug marketed by Provensis and is included in one NDA. It is available from one supplier. There are fourteen patents protecting this drug. Additional details are available on the VARITHENA profile page.

The generic ingredient in VARITHENA is polidocanol. Two suppliers are listed for this compound. Additional details are available on the polidocanol profile page.
Summary for 205098
Tradename:VARITHENA
Applicant:Provensis
Ingredient:polidocanol
Patents:14
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 205098
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VARITHENA polidocanol SOLUTION;INTRAVENOUS 205098 NDA Biocompatibles, Inc. 60635-118 60635-118-01 1 KIT in 1 BOX (60635-118-01) * 1 CANISTER in 1 POUCH > 45 mL in 1 CANISTER * 1 CANISTER in 1 POUCH > 303 mL in 1 CANISTER
VARITHENA polidocanol SOLUTION;INTRAVENOUS 205098 NDA Biocompatibles, Inc. 60635-123 60635-123-01 1 KIT in 1 BOX (60635-123-01) * 1 APPLICATOR in 1 BLISTER PACK > 45 mL in 1 APPLICATOR * 1 CANISTER in 1 POUCH > 303 mL in 1 CANISTER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength180MG/18ML (10MG/ML)
Approval Date:Nov 25, 2013TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:May 26, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:A METHOD OF GENERATING AN INJECTABLE FOAM OF CONTROLLED DENSITY AND BUBBLE SIZE
Patent:➤ Sign UpPatent Expiration:Jul 19, 2022Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:May 26, 2020Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 205098

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Provensis VARITHENA polidocanol SOLUTION;INTRAVENOUS 205098-001 Nov 25, 2013 ➤ Sign Up ➤ Sign Up
Provensis VARITHENA polidocanol SOLUTION;INTRAVENOUS 205098-001 Nov 25, 2013 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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