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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Information Request Email, March 21, 2013 - Novoeight

 

From:                    Pracht, Leigh
Sent:                      Thursday, March 21, 2013 3:50 PM
To:                         'CDCA (Cindy Cao)'
Subject:                 UNII Codes for STN 125466/0          Novo Nordisk Inc.   Antihemophilic Factor (Recombinant), Plasma/Albumin Free [NovoEight]
Our Reference: STN 125466/0
Cindy Cao, PhD
March 21, 2013
Sent by email
 
Dr. Cao,
 
Please find below the UNII codes that have been assigned to STN 125466, Antihemophilic Factor (Recombinant), Plasma/Albumin Free.
 
 
 

Ingredient
Preferred Substance Name
UNII
turoctocog alfa
TUROCTOCOG ALFA
969NZA3X9T
L‐Histidine
HISTIDINE
4QD397987E
Sucrose
SUCROSE
C151H8M554
Polysorbate 80
POLYSORBATE 80
6OZP39ZG8H
Sodium Chloride
SODIUM CHLORIDE
451W47IQ8X
L‐Methionine
METHIONINE
AE28F7PNPL
Calcium chloride dihydrate
CALCIUM CHLORIDE
M4I0D6VV5M
Water for injections
WATER
059QF0KO0R
------(b)(4)-------
------(b)(4)-------
----(b)(4)----
------(b)(4)-------
------(b)(4)-------
----(b)(4)----
----(b)(4)----
----(b)(4)----
----(b)(4)----

 
 
Best regards,
Leigh A. Pracht

Regulatory Project Manager
FDA/CBER/OBRR/DBA
WOC1; RM562N; HFM-380
1401 Rockville Pike
Rockville, MD 20852
Telephone: 301-827-6116
Fax: 301- 827-2857
Leigh.Pracht@fda.hhs.gov
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