polidocanol Injection

Brand(s)
Asclera
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Merz North America, Inc (2014-07-22)
Oldest Current Product
2010-06-01
License(s)
NDA
RxNORM
INJECTION\POLIDOCANOL
FDAOB
INTRAVENOUS\SOLUTION\POLIDOCANOL
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\POLIDOCANOL
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\POLIDOCANOL

product(s) by strength(s)

2 ml polidocanol 10 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1467830221AscleraNDAMerz North America, Inc2010-06-01POLIDOCANOLINTRAVENOUSINJECTION, SOLUTIONNDA02120190550274-6605-44de-8c25-c5591080270f

2 ml polidocanol 5 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1467830121AscleraNDAMerz North America, Inc2010-06-01POLIDOCANOLINTRAVENOUSINJECTION, SOLUTIONNDA02120190550274-6605-44de-8c25-c5591080270f

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drugin other drug docs
1NDA021201ASCLERACHEMISCHE FABRIK KREUSSLER & CO. GMBH2010-03-30NEW CHEMICAL ENTITY [2015-03-30]NDA021201_001, NDA021201_002polidocanol Injectable Foam
2NDA205098VARITHENAPROVENSIS LTD2013-11-25p7814943, A METHOD OF GENERATING AN INJECTABLE FOAM OF CONTROLLED DENSITY AND BUBBLE SIZE, SUBSTANCE
p7842283, SUBSTANCE
p7842282, A METHOD OF GENERATING AN INJECTABLE FOAM OF CONTROLLED DENSITY AND BUBBLE SIZE
p8122917, SUBSTANCE
pRE40640, A METHOD OF USING A SCLEROSING AGENT FOR THE TREATMENT OF INCOMPETENT GREAT SAPHENOUS VEINS, SUBSTANCE
p6942165, SUBSTANCE
p7357336, A METHOD OF GENERATING AN INJECTABLE FOAM OF CONTROLLED DENSITY AND BUBBLE SIZE
p8734833, SUBSTANCE
p8323677
p7025290, A METHOD OF GENERATING AN INJECTABLE FOAM OF CONTROLLED DENSITY AND BUBBLE SIZE, SUBSTANCE
p6846412, SUBSTANCE
p7731986, A METHOD OF INTRAVENOUS INJECTION USING ULTRASOUND GUIDANCE, SUBSTANCE
pRE38919, SUBSTANCE
p6572873, A METHOD OF GENERATING AN INJECTABLE FOAM OF CONTROLLED DENSITY AND BUBBLE SIZE
p7604185, A METHOD OF USING A SCLEROSING AGENT FOR THE TREATMENT OF INCOMPETENT GREAT SAPHENOUS VEINS, SUBSTANCE
NDA205098_001polidocanol Injectable Foam

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA021201_001RXPOLIDOCANOL (10MG/2ML)INTRAVENOUSSOLUTIONFalse2010-03-30ASCLERA
2NDA021201_002RXPOLIDOCANOL (20MG/2ML)INTRAVENOUSSOLUTIONTrue2010-03-30ASCLERA
3NDA205098_001RXPOLIDOCANOL (180MG/18ML)INTRAVENOUSSOLUTIONTrue2013-11-25VARITHENA

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6572873 (view patent)2020-05-26NDA205098polidocanol Injectable Foam
2p6846412 (view patent)2022-07-19NDA205098polidocanol Injectable Foam
3p6942165 (view patent)2020-05-26NDA205098polidocanol Injectable Foam
4p7025290 (view patent)2020-05-26NDA205098polidocanol Injectable Foam
5p7357336 (view patent)2020-05-26NDA205098polidocanol Injectable Foam
6p7604185 (view patent)2020-05-26NDA205098polidocanol Injectable Foam
7p7731986 (view patent)2024-11-17NDA205098polidocanol Injectable Foam
8p7814943 (view patent)2027-11-19NDA205098polidocanol Injectable Foam
9p7842282 (view patent)2020-05-26NDA205098polidocanol Injectable Foam
10p7842283 (view patent)2020-05-26NDA205098polidocanol Injectable Foam
11p8122917 (view patent)2024-09-09NDA205098polidocanol Injectable Foam
12p8323677 (view patent)2020-05-26NDA205098polidocanol Injectable Foam
13p8734833 (view patent)2020-05-26NDA205098polidocanol Injectable Foam
14pRE38919 (view patent)2014-10-14NDA205098polidocanol Injectable Foam
15pRE40640 (view patent)2016-10-14NDA205098polidocanol Injectable Foam

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
190550274-6605-44de-8c25-c5591080270f (view SPL)These highlights do not include all the information needed to use Asclera Injection safely and effectively. See full prescribing information for Asclera. Asclera (polidocanol) Injection, for intravenous use Initial U.S. Approval: 2010prescriptionHuman PrescriptionMerz North America, IncMANUFACTURE2014-07-2219467830121, 467830221

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII