GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24379
Submission : 2011-02-22
Status : Inactive
Type : IV

NDC Package Code : 49452-8073
Start Marketing Date : 2021-09-22
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT

NDC Package Code : 14639-8432
Start Marketing Date : 2014-07-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT

NDC Package Code : 14639-8432
Start Marketing Date : 2016-06-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

NDC Package Code : 14639-8432
Start Marketing Date : 2016-06-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : BULK INGREDIENT

NDC Package Code : 51927-5138
Start Marketing Date : 2024-01-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING

NDC Package Code : 14639-8432
Start Marketing Date : 2016-02-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24379
Submission : 2011-02-22
Status : Inactive
Type : IV

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FINISHED DOSAGE FORMULATIONS
EXCIPIENTS BY APPLICATIONS
Application : Parenteral
Excipient Details : Solubilizer agent, increasing solubility of hydrophobic peptides and proteins and denaturing proteins. Also used in cell cultures as a nutrient.
Pharmacopoeia Ref : On Request
Technical Specs : Low bacteria endotoxins, low bioburden (TAMC/TYMC). Customised pa...
Ingredient(s) : Urea
Application : Solubilizers
Excipient Details : Solubilizer agent, increasing solubility of hydrophobic peptides and proteins and denaturing proteins. Also used in cell cultures as a nutrient.
Pharmacopoeia Ref : On Request
Technical Specs : Low bacteria endotoxins, low bioburden (TAMC/TYMC). Customised pa...
Ingredient(s) : Urea
MARKET PLACE
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28 Feb 2025
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01 Dec 2022
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REF. STANDARDS & IMPURITIES