kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM NITRITE (UNII: M0KG633D4F) (NITRITE ION - UNII:J39976L608)

Available from:

Food and Drug Administration

Authorization status:

New Drug Application

Summary of Product characteristics

INDEXING - PRODUCT CONCEPT
-
FOOD AND DRUG ADMINISTRATION
REFERENCE LABEL SET ID: FF4941B3-9901-4AAB-ADCF-C5327BEDE34E
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APPLICATION PRODUCT CONCEPT
kit
PRODUCT INFORMATION
PRODUCT T YPE
INDEXING - PRODUCT CONCEPT
ITE M CODE (SOURCE )
3bb2a 0 6 a -6 4e 7-138 0 -e 8 d7-18 9 718 b0 4a 6 3
QUANTITY OF PARTS
PART #
PACKAGE QUANTITY
TOTAL PRODUCT QUANTITY
PA RT 1
10 mL
PA RT 2
50 mL
PART 1 OF 2
injection
PRODUCT INFORMATION
ITE M CODE (SOURCE )
be 4be 4e f-36 29 -2c a c -c 0 11-0 2e a 9 55a 79 50
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
SO DIUM NITRITE (UNII: M0 KG6 33D4F) (NITRITE ION - UNII:J39 9 76 L6 0
8 )
SODIUM NITRITE
30 mg in 1 mL
PART 2 OF 2
injection
PRODUCT INFORMATION
ITE M CODE (SOURCE )
0 6 8 79 0 0 2-6 de a -3c 2f-71c 1-6 1456 8 bd0 e 0 6
ACTIVE INGREDIENT/ACTIVE MOIETY
Food and Drug Administration
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
SO DIUM THIO SULFATE (UNII: HX10 32V43M) (THIOSULFATE ION - UNII:LLT6
XV39 PY)
SODIUM THIOSULFATE 250 mg in 1 mL
APPLICATION PRODUCT CONCEPT
PRODUCT INFORMATION
PRODUCT T YPE
INDEXING - PRODUCT CONCEPT
ITE M CODE (SOURCE )
d10 6 8 0 8 e -30 51-9 6 a 1-a a a 3-e 450 4dd8 b3d6
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
NDA
NDA20 1444
LABELER -
Food and Drug Administration (927645523)
Revised: 12/2017