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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 NDA: 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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength180MG/18ML (10MG/ML)
Approval Date:Nov 25, 2013TE:RLD:Yes
Patent:6,846,412Patent Expiration:Jul 19, 2022Product Flag?YSubstance Flag?Delist Request?
Patent:6,942,165Patent Expiration:May 26, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:7,842,283Patent Expiration:May 26, 2020Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 205098

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Provensis
VARITHENA
polidocanol
SOLUTION;INTRAVENOUS205098-001Nov 25, 2013RE38919► subscribe
Provensis
VARITHENA
polidocanol
SOLUTION;INTRAVENOUS205098-001Nov 25, 2013RE40640► subscribe
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