NDC Code(s) : 60635-107-01, 60635-111-01, 60635-118-01, 60635-133-01, 60635-123-01
Packager : Biocompatibles, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Varithenapolidocanol KIT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60635-107
Route of Administration DEA Schedule
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
POTASSIUM PHOSPHATE, MONOBASIC(UNII: 4J9FJ0HL51)0.85 mg in 1 mL
ALCOHOL(UNII: 3K9958V90M)42 mg in 1 mL
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE(UNII: 94255I6E2T)2.4 mg in 1 mL
CARBON DIOXIDE(UNII: 142M471B3J)15.8 mL in 1 mL
OXYGEN(UNII: S88TT14065)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60635-107-011 in 1 CARTON 22/12/2017
11 in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205098 12/22/2017 04/30/2023
Varithenapolidocanol KIT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60635-111
Route of Administration DEA Schedule
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
POTASSIUM PHOSPHATE, MONOBASIC(UNII: 4J9FJ0HL51)0.85 mg in 1 mL
ALCOHOL(UNII: 3K9958V90M)42 mg in 1 mL
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE(UNII: 94255I6E2T)2.4 mg in 1 mL
CARBON DIOXIDE(UNII: 142M471B3J)15.8 mL in 1 mL
OXYGEN(UNII: S88TT14065)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60635-111-011 in 1 PACKAGE 22/12/2017
11 in 1 CARTON
11 in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205098 12/22/2017 04/30/2023
Varithenapolidocanol KIT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60635-118
Route of Administration DEA Schedule
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
POTASSIUM PHOSPHATE, MONOBASIC(UNII: 4J9FJ0HL51)0.85 mg in 1 mL
ALCOHOL(UNII: 3K9958V90M)42 mg in 1 mL
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE(UNII: 94255I6E2T)2.4 mg in 1 mL
CARBON DIOXIDE(UNII: 142M471B3J)15.8 mL in 1 mL
OXYGEN(UNII: S88TT14065)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60635-118-011 in 1 CARTON 22/06/2016
11 in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205098 07/10/2014
Varithenapolidocanol KIT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60635-133
Route of Administration DEA Schedule
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
POTASSIUM PHOSPHATE, MONOBASIC(UNII: 4J9FJ0HL51)0.85 mg in 1 mL
ALCOHOL(UNII: 3K9958V90M)42 mg in 1 mL
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE(UNII: 94255I6E2T)2.4 mg in 1 mL
CARBON DIOXIDE(UNII: 142M471B3J)15.8 mL in 1 mL
OXYGEN(UNII: S88TT14065)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60635-133-011 in 1 PACKAGE 22/06/2016
11 in 1 CARTON
11 in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205098 11/25/2013
Varithenapolidocanol KIT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60635-123
Route of Administration DEA Schedule
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
POTASSIUM PHOSPHATE, MONOBASIC(UNII: 4J9FJ0HL51)0.85 mg in 1 mL
ALCOHOL(UNII: 3K9958V90M)42 mg in 1 mL
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE(UNII: 94255I6E2T)2.4 mg in 1 mL
CARBON DIOXIDE(UNII: 142M471B3J)15.8 mL in 1 mL
OXYGEN(UNII: S88TT14065)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60635-123-011 in 1 BOX 22/06/2016
11 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205098 07/10/2014 01/09/2017

LABELER - Biocompatibles, Inc.(024194234)

REGISTRANT - Provensis Ltd(236996703)

PRINCIPAL DISPLAY PANEL

Principal Display Panel - Varithena Bi-Canister - NDC 60635-107-01

Principal Display Panel - Varithena Bi-Canister - NDC 60635-107-01

PRINCIPAL DISPLAY PANEL

Principal Display Panel - Varithena Pouch Label - NDC 60635-107-01

Principal Display Panel - Varithena Pouch Label - NDC 60635-107-01

PRINCIPAL DISPLAY PANEL

Principal Display Panel - Varithena Canister Label - NDC 60635-007-01

Principal Display Panel - Varithena Canister Label - NDC 60635-007-01

PRINCIPAL DISPLAY PANEL

Principal Display Panel - Varithena Ancillary Pack

Principal Display Panel - Varithena Ancillary Pack

PRINCIPAL DISPLAY PANEL

Principal Display Panel - Varithena Convenience Box Carton - NDC 60635-111-01

Principal Display Panel - Varithena Convenience Box Carton - NDC 60635-111-01

PRINCIPAL DISPLAY PANEL

Principal Display Panel - Varithena Canister Label - NDC 60635-018-01

Principal Display Panel - Varithena Canister Label - NDC 60635-018-01

PRINCIPAL DISPLAY PANEL

Principal Display Panel - Varithena Pouch Label - NDC 60635-118-01

Principal Display Panel - Varithena Pouch Label - NDC 60635-118-01

PRINCIPAL DISPLAY PANEL

Principal Display Panel - Varithena Bi-Canister Box - NDC 60635-118-01

Principal Display Panel - Varithena Bi-Canister Box - NDC 60635-118-01

PRINCIPAL DISPLAY PANEL

Principal Display Panel - Varithena Universal Administration Pack

Principal Display Panel - Varithena Universal Administration Pack