12 Apr 2025
// REUTERS
12 Apr 2025
// FIERCE PHARMA
12 Apr 2025
// FIERCE PHARMA
Latest Content by PharmaCompass
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01 1Apixaban
02 1Beclomethasone Dipropionate
03 1Efavirenz
04 1Fluorouracil
05 1Moxidectin
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01 120130610-186-I-320-02
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01 170366-001
02 170366-002
03 170366-003
04 170366-004
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USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10262
Submission : 1993-05-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5749
Submission : 1985-03-04
Status : Inactive
Type : II
NDC Package Code : 70366-001
Start Marketing Date : 2016-02-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kolon Pharmaceutical Co., Ltd.
Registration Date : 2013-06-10
Registration Number : 20130610-186-I-320-02
Manufacturer Name : Microchem SRL@Farmabios SpA (all processes except micronization process)
Manufacturer Address : Fiorenzuola D`Arda (PC) - Via Turati 2, Italy.@Gropello Cairoli (PV) - Via Pavia, 1, Italy.
NDC Package Code : 70366-002
Start Marketing Date : 2016-02-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 70366-003
Start Marketing Date : 2016-06-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 70366-004
Start Marketing Date : 2019-11-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT