Asclera
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
Approved
Approval ID
bb1f342b-5352-4059-a0b2-e60fd652fd28
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 9, 2023
Manufacturers
FDA
Methapharm, Inc
DUNS: 066672887
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
POLIDOCANOL
PRODUCT DETAILS
NDC Product Code67850-141
Application NumberNDA021201
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateDecember 10, 2021
Generic NamePOLIDOCANOL
INGREDIENTS (5)
POLIDOCANOLActive
Quantity: 0.01000 g in 1 mL
Code: 0AWH8BFG9A
Classification: ACTIB
WATERInactive
Quantity: 0.93875 g in 1 mL
Code: 059QF0KO0R
Classification: IACT
MONOBASIC POTASSIUM PHOSPHATEInactive
Quantity: 0.00085 g in 1 mL
Code: 4J9FJ0HL51
Classification: IACT
ALCOHOLInactive
Quantity: 0.04200 g in 1 mL
Code: 3K9958V90M
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Quantity: 0.00240 g in 1 mL
Code: GR686LBA74
Classification: IACT
POLIDOCANOL
PRODUCT DETAILS
NDC Product Code67850-140
Application NumberNDA021201
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateDecember 10, 2021
Generic NamePOLIDOCANOL
INGREDIENTS (5)
WATERInactive
Quantity: 0.94437 g in 1 mL
Code: 059QF0KO0R
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Quantity: 0.00120 g in 1 mL
Code: GR686LBA74
Classification: IACT
POLIDOCANOLActive
Quantity: 0.00500 g in 1 mL
Code: 0AWH8BFG9A
Classification: ACTIB
ALCOHOLInactive
Quantity: 0.04200 g in 1 mL
Code: 3K9958V90M
Classification: IACT
MONOBASIC POTASSIUM PHOSPHATEInactive
Quantity: 0.00043 g in 1 mL
Code: 4J9FJ0HL51
Classification: IACT