NDC Code(s) : 53270-3120-1, 53270-3500-1, 53270-3100-1, 53270-3000-1, 53270-3300-1
Packager : Cangene BioPharma, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

WINRHOrho (d) immune globulin LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53270-3120
Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HUMAN IMMUNOGLOBULIN G(UNII: 66Y330CJHS)
(HUMAN IMMUNOGLOBULIN G - UNII:66Y330CJHS) 		HUMAN IMMUNOGLOBULIN G600 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
MALTOSE(UNII: XJ6S9RV06F)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:53270-3120-11 in 1 CARTON 31/03/2005
10.5 mL in 1 VIAL, SINGLE-DOSE Type 6: Drug/Biologic Combination
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103649 03/31/2005
WINRHOrho (d) immune globulin LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53270-3500
Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HUMAN IMMUNOGLOBULIN G(UNII: 66Y330CJHS)
(HUMAN IMMUNOGLOBULIN G - UNII:66Y330CJHS) 		HUMAN IMMUNOGLOBULIN G2500 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
MALTOSE(UNII: XJ6S9RV06F)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:53270-3500-11 in 1 CARTON 31/03/2005
12.2 mL in 1 VIAL, SINGLE-DOSE Type 6: Drug/Biologic Combination
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103649 03/31/2005
WINRHOrho (d) immune globulin LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53270-3100
Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HUMAN IMMUNOGLOBULIN G(UNII: 66Y330CJHS)
(HUMAN IMMUNOGLOBULIN G - UNII:66Y330CJHS) 		HUMAN IMMUNOGLOBULIN G5000 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
MALTOSE(UNII: XJ6S9RV06F)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:53270-3100-11 in 1 CARTON 31/03/2004
14.4 mL in 1 VIAL, SINGLE-DOSE Type 6: Drug/Biologic Combination
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103649 03/31/2004
WINRHOrho (d) immune globulin LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53270-3000
Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HUMAN IMMUNOGLOBULIN G(UNII: 66Y330CJHS)
(HUMAN IMMUNOGLOBULIN G - UNII:66Y330CJHS) 		HUMAN IMMUNOGLOBULIN G15000 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
MALTOSE(UNII: XJ6S9RV06F)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:53270-3000-11 in 1 CARTON 31/03/2005
113 mL in 1 VIAL, SINGLE-DOSE Type 6: Drug/Biologic Combination
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103649 03/31/2005
WINRHOrho (d) immune globulin LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53270-3300
Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HUMAN IMMUNOGLOBULIN G(UNII: 66Y330CJHS)
(HUMAN IMMUNOGLOBULIN G - UNII:66Y330CJHS) 		HUMAN IMMUNOGLOBULIN G1500 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
MALTOSE(UNII: XJ6S9RV06F)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:53270-3300-11 in 1 CARTON 31/03/2005
11.3 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103649 03/31/2005

PRINCIPAL DISPLAY PANEL

Principal Display Panel - WinRho SDF Liquid 600 IU

WinRho ® SDF Liquid

600 IU (120µg)

Target Vol.: 0.5 mL

PRINCIPAL DISPLAY PANEL

Principal Display Panel - WinRho SDF Liquid 600 IU

Rh o(D) Immune Globulin Intravenous (Human)

WinRho ® SDF Liquid

600 IU (120µg)

Target Vol.: 0.5 mL

For Intravenous or Intramuscular Administration

Rx Only

PRINCIPAL DISPLAY PANEL

Principal Display Panel - WinRho SDF Liquid 1500 IU

WinRho ® SDF Liquid

1500 IU (300µg)

Target Vol.: 1.3 mL

PRINCIPAL DISPLAY PANEL

Principal Display Panel - WinRho SDF Liquid 1500 IU

Rh o(D) Immune Globulin Intravenous (Human)

WinRho ® SDF Liquid

1500 IU (300µg)

Target Vol.: 1.3 mL

For Intravenous or Intramuscular Administration

Rx Only

PRINCIPAL DISPLAY PANEL

Principal Display Panel - WinRho SDF Liquid 2500 IU

WinRho ® SDF Liquid

2500 IU (500µg)

Target Vol.: 2.2 mL

PRINCIPAL DISPLAY PANEL

Principal Display Panel - WinRho SDF Liquid 2500 IU

Rh o(D) Immune Globulin Intravenous (Human)

WinRho ® SDF Liquid

2500 IU (500µg)

Target Vol.: 2.2 mL

For Intravenous or Intramuscular Administration

Rx Only

PRINCIPAL DISPLAY PANEL

Principal Display Panel - WinRho SDF Liquid 5000 IU

WinRho ® SDF Liquid

5000 IU (1000µg)

Target Vol.: 4.4 mL

PRINCIPAL DISPLAY PANEL

Principal Display Panel - WinRho SDF Liquid 5000 IU

Rh o(D) Immune Globulin Intravenous (Human)

WinRho ® SDF Liquid

5000 IU (1000µg)

Target Vol.: 4.4 mL

For Intravenous or Intramuscular Administration

Rx Only

PRINCIPAL DISPLAY PANEL

Principal Display Panel - WinRho SDF Liquid 15000 IU

WinRho ® SDF Liquid

15000 IU (3000µg)

Target Vol.: 13.0 mL

PRINCIPAL DISPLAY PANEL

Principal Display Panel - WinRho SDF Liquid 15000 IU

Rh o(D) Immune Globulin Intravenous (Human)

WinRho ® SDF Liquid

15000 IU (3000µg)

Target Vol.: 13.0 mL

For Intravenous or Intramuscular Administration

Rx Only