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Generated: May 20, 2019

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Details for New Drug Application (NDA): 021201

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NDA 021201 describes ASCLERA, which is a drug marketed by Chemisch Fbrk Krsslr and is included in one NDA. It is available from one supplier. Additional details are available on the ASCLERA profile page.

The generic ingredient in ASCLERA is polidocanol. Two suppliers are listed for this compound. Additional details are available on the polidocanol profile page.
Summary for 021201
Applicant:Chemisch Fbrk Krsslr
Formulation / Manufacturing:see details
Pharmacology for NDA: 021201
Mechanism of ActionSclerosing Activity
Physiological EffectVascular Sclerosing Activity
Suppliers and Packaging for NDA: 021201
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ASCLERA polidocanol SOLUTION;INTRAVENOUS 021201 NDA Merz North America, Inc 46783-121 46783-121-52 2 mL in 1 AMPULE (46783-121-52)
ASCLERA polidocanol SOLUTION;INTRAVENOUS 021201 NDA Merz North America, Inc 46783-221 46783-221-52 2 mL in 1 AMPULE (46783-221-52)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength10MG/2ML (5MG/ML)
Approval Date:Mar 30, 2010TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength20MG/2ML (10MG/ML)
Approval Date:Mar 30, 2010TE:RLD:Yes

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