01 1BioSpectra
02 4Merck & Co
03 1Pcca
04 1Spectrum Chemical
01 1Inactive
02 6Blank
01 7Blank
01 7Blank
01 7Blank
01 7Blank
01 414639-8432
02 149452-8073
03 151927-5138
04 1Blank
01 7Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24379
Submission : 2011-02-22
Status : Inactive
Type : IV
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 : 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 : 2016-06-15
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 : 14639-8432
Start Marketing Date : 2016-02-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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
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