SUPPLIERS
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11051
Submission : 1994-08-01
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37618
Submission : 2023-03-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33205
Submission : 2018-10-11
Status : Active
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
Glucose Monohydrate, For Use In The Manufacture ...
Certificate Number : R1-CEP 1996-030 - Rev 04
Status : Valid
Issue Date : 2015-12-21
Type : Chemical
Substance Number : 178
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
Registration Number : 222MF10150
Registrant's Address : La Haute Loge LESTREM FRANCE
Initial Date of Registration : 2010-05-17
Latest Date of Registration : 2018-10-12
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
NDC Package Code : 69507-001
Start Marketing Date : 2015-01-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 50516-001
Start Marketing Date : 2014-05-07
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 52647-001
Start Marketing Date : 2014-06-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 40087-1001
Start Marketing Date : 2022-01-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]LISTED SUPPLIERS
FINISHED DOSAGE FORMULATIONS
FDF DOSSIERS SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Listed Dossiers
DEXTROSE MONOHYDRATE
Route : INTRAVENOUS
CAS : 77938-63-7
UNII : LX22YL083G
Potency Amount : 5
Potency Unit : %
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Corporate PDF
DEXTROSE MONOHYDRATE
Route : INTRAVENOUS
CAS : 77938-63-7
UNII : LX22YL083G
Potency Amount : 5.05
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
DEXTROSE MONOHYDRATE
Route : INTRAVENOUS
CAS : 77938-63-7
UNII : LX22YL083G
Potency Amount : 5
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
DEXTROSE MONOHYDRATE
Route : NASAL
CAS : 77938-63-7
UNII : LX22YL083G
Potency Amount : 5.5
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
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Corporate PDF
DEXTROSE MONOHYDRATE
Route : NASAL
CAS : 77938-63-7
UNII : LX22YL083G
Potency Amount : 0
Potency Unit : NA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
DEXTROSE MONOHYDRATE
Route : ORAL
CAS : 77938-63-7
UNII : LX22YL083G
Potency Amount : 46.2
Potency Unit : MG
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Corporate PDF
EXCIPIENTS BY APPLICATIONS
Fillers Diluents Binders
Parenteral
Brand Name : LYCADEX® BIOPHARMA
Application : Parenteral
Excipient Details : It is used upstream in the cell culture process as an energy and carbon source during the production of therapeutic proteins
Application : Parenteral
Excipient Details : It is a dextrose monohydrate pyrogen-free that is a physiological sugar used to provide excipient and API benefits.
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