NDC Code(s) : 72205-009-30, 72205-010-30, 72205-010-90
Packager : Novadoz Pharmaceuticals LLC

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

SILODOSIN SILODOSIN CAPSULE
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:72205-009
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SILODOSIN(UNII: CUZ39LUY82)
(SILODOSIN - UNII:CUZ39LUY82) 		SILODOSIN4 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SHELLAC(UNII: MB5IUD6JUA)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
GELATIN(UNII: 2G86QN327L)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
STARCH, CORN(UNII: O8232NY3SJ)
MAGNESIUM ALUMINOMETASILICATE TYPE IA(UNII: 7LVU907546)
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 15 mm
Flavor Imprint Code S;4mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72205-009-3030 in 1 BOTTLE Type 0: Not a Combination Product12/03/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210687 12/03/2018
SILODOSIN SILODOSIN CAPSULE
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:72205-010
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SILODOSIN(UNII: CUZ39LUY82)
(SILODOSIN - UNII:CUZ39LUY82) 		SILODOSIN8 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SHELLAC(UNII: MB5IUD6JUA)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
GELATIN(UNII: 2G86QN327L)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
STARCH, CORN(UNII: O8232NY3SJ)
MAGNESIUM ALUMINOMETASILICATE TYPE IA(UNII: 7LVU907546)
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code S;8mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72205-010-3030 in 1 BOTTLE Type 0: Not a Combination Product12/03/2018
2NDC:72205-010-9090 in 1 BOTTLE Type 0: Not a Combination Product12/03/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210687 12/03/2018

LABELER - Novadoz Pharmaceuticals LLC(081109687)

REGISTRANT - Novadoz Pharmaceuticals LLC(081109687)

Establishment
Name Address ID/FEI Business Operations
MSN LABORATORIES PRIVATE LIMITED 650786952 ANALYSIS(72205-009, 72205-010), MANUFACTURE(72205-009, 72205-010)

PRINCIPAL DISPLAY PANEL

4mg-container-label-30s-count

 

4mg-30s-cntr

    

8mg-container-label-30s-count

4mg-30s-cntr

8mg-container-label-90s-count

  

4mg-30s-cntr