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WinRho SDF

These highlights do not include all the information needed to use WinRho SDF safely and effectively. See full prescribing information for WinRho SDF. WinRho SDF [Rh(D) Immune Globulin Intravenous (Human)] Solution for Intravenous or Intramuscular Injection Initial U.S. Approval: 1995

Approved
Approval ID

b8809e8b-9a6f-47d3-80de-fe46ae79f7cd

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 5, 2020

Manufacturers
FDA

Saol Therapeutics Inc.

DUNS: 080040201

Products 4

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

rho (d) immune globulin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70257-300
Application NumberBLA103649
Product Classification
M
Marketing Category
C73585
G
Generic Name
rho (d) immune globulin
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateApril 10, 2020
FDA Product Classification

INGREDIENTS (3)

HUMAN RHO(D) IMMUNE GLOBULINActive
Quantity: 15000 [iU] in 1 1
Code: 48W7181FLP
Classification: ACTIB
MALTOSEInactive
Code: XJ6S9RV06F
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT

rho (d) immune globulin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70257-350
Application NumberBLA103649
Product Classification
M
Marketing Category
C73585
G
Generic Name
rho (d) immune globulin
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateApril 10, 2020
FDA Product Classification

INGREDIENTS (3)

HUMAN RHO(D) IMMUNE GLOBULINActive
Quantity: 2500 [iU] in 1 1
Code: 48W7181FLP
Classification: ACTIB
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
MALTOSEInactive
Code: XJ6S9RV06F
Classification: IACT

rho (d) immune globulin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70257-330
Application NumberBLA103649
Product Classification
M
Marketing Category
C73585
G
Generic Name
rho (d) immune globulin
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateApril 10, 2020
FDA Product Classification

INGREDIENTS (3)

HUMAN RHO(D) IMMUNE GLOBULINActive
Quantity: 1500 [iU] in 1 1
Code: 48W7181FLP
Classification: ACTIB
MALTOSEInactive
Code: XJ6S9RV06F
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT

rho (d) immune globulin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70257-310
Application NumberBLA103649
Product Classification
M
Marketing Category
C73585
G
Generic Name
rho (d) immune globulin
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateApril 10, 2020
FDA Product Classification

INGREDIENTS (3)

MALTOSEInactive
Code: XJ6S9RV06F
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HUMAN RHO(D) IMMUNE GLOBULINActive
Quantity: 5000 [iU] in 1 1
Code: 48W7181FLP
Classification: ACTIB

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WinRho SDF - FDA Drug Approval Details