01 1Apicore LLC
02 1Catalytica
03 1Dipharma
04 1Emcure Pharmaceuticals
05 1Olon S.p.A
06 1Sifavitor srl
07 1Blank
01 3India
02 3Italy
03 1Blank
01 3Active
02 3Inactive
03 1Blank
01 7Blank
01 7Blank
01 7Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20365
Submission : 2007-03-22
Status : Active
Type : II
NDC Package Code : 46438-0056
Start Marketing Date : 2006-08-16
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8381
Submission : 1989-11-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23673
Submission : 2010-04-02
Status : Active
Type : II
NDC Package Code : 14593-825
Start Marketing Date : 2023-12-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (15kg/15kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21234
Submission : 2008-01-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7896
Submission : 1989-01-28
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7994
Submission : 1989-03-13
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
NDC Package Code : 17337-0539
Start Marketing Date : 2017-06-21
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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