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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 NDA: 021201

Chemisch Fbrk Krsslr

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
SOLUTION;INTRAVENOUS 021201 NDA Merz North America, Inc 46783-121 46783-121-52 2 mL in 1 AMPULE (46783-121-52)
SOLUTION;INTRAVENOUS 021201 NDA Merz North America, Inc 46783-221 46783-221-52 2 mL in 1 AMPULE (46783-221-52)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength10MG/2ML (5MG/ML)
Approval Date:Mar 30, 2010TE:RLD:No

Summary 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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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.