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)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 467830221 | Asclera | NDA | Merz North America, Inc | 2010-06-01 | POLIDOCANOL | INTRAVENOUS | INJECTION, SOLUTION | NDA021201 | 90550274-6605-44de-8c25-c5591080270f |
2 ml polidocanol 5 mg/ml injection
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 467830121 | Asclera | NDA | Merz North America, Inc | 2010-06-01 | POLIDOCANOL | INTRAVENOUS | INJECTION, SOLUTION | NDA021201 | 90550274-6605-44de-8c25-c5591080270f |
application(s)
| # | id | title | applicant | approved | patent | exclusivity | approved drug | in other drug docs |
|---|---|---|---|---|---|---|---|---|
| 1 | NDA021201 | ASCLERA | CHEMISCHE FABRIK KREUSSLER & CO. GMBH | 2010-03-30 | NEW CHEMICAL ENTITY [2015-03-30] | NDA021201_001, NDA021201_002 | polidocanol Injectable Foam | |
| 2 | NDA205098 | VARITHENA | PROVENSIS LTD | 2013-11-25 | p7814943, 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_001 | polidocanol Injectable Foam |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | NDA021201_001 | RX | POLIDOCANOL (10MG/2ML) | INTRAVENOUS | SOLUTION | False | 2010-03-30 | ASCLERA |
| 2 | NDA021201_002 | RX | POLIDOCANOL (20MG/2ML) | INTRAVENOUS | SOLUTION | True | 2010-03-30 | ASCLERA |
| 3 | NDA205098_001 | RX | POLIDOCANOL (180MG/18ML) | INTRAVENOUS | SOLUTION | True | 2013-11-25 | VARITHENA |
patent(s)
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 90550274-6605-44de-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: 2010 | prescription | Human Prescription | Merz North America, Inc | MANUFACTURE | 2014-07-22 | 19 | 467830121, 467830221 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII