NDC 70257-532

Cytogam

Cytomegalovirus Immune Globulin Intravenous (human)

Cytogam is a Intravenous Liquid in the Plasma Derivative category. It is labeled and distributed by Saol Therapeutics Inc.. The primary component is Human Cytomegalovirus Immune Globulin.

Product ID70257-532_2a40733c-106b-41cf-94f0-f10a03180ac8
NDC70257-532
Product TypePlasma Derivative
Proprietary NameCytogam
Generic NameCytomegalovirus Immune Globulin Intravenous (human)
Dosage FormLiquid
Route of AdministrationINTRAVENOUS
Marketing Start Date2020-10-30
Marketing CategoryBLA / BLA
Application NumberBLA103189
Labeler NameSaol Therapeutics Inc.
Substance NameHUMAN CYTOMEGALOVIRUS IMMUNE GLOBULIN
Active Ingredient Strength50 mg/mL
Pharm ClassesHuman Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Virus Neutralization [MoA],Virus-specific Hyperimmune Globulins [EXT],Immunoglobulins [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 70257-532-51

1 VIAL, GLASS in 1 CARTON (70257-532-51) > 50 mL in 1 VIAL, GLASS (70257-532-50)
Marketing Start Date2020-10-30
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Cytogam" or generic name "Cytomegalovirus Immune Globulin Intravenous (human)"

NDCBrand NameGeneric Name
44206-532CytogamHuman Cytomegalovirus Immune Globulin
70257-532CytogamCytomegalovirus Immune Globulin Intravenous (Human)

Trademark Results [Cytogam]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CYTOGAM
CYTOGAM
85238921 4025755 Dead/Cancelled
CSL Behring AG
2011-02-10
CYTOGAM
CYTOGAM
77522611 not registered Dead/Abandoned
CSL Behring AG
2008-07-15
CYTOGAM
CYTOGAM
74178919 1742103 Live/Registered
SAOL BERMUDA LIMITED
1991-06-21

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