01 1COSMA S.p.A
02 1Chemi SpA
03 1Fleming Laboratories
04 1Napp Technologies
05 1POLI INDUSTRIA CHIMICA SPA
06 1Ramdev Chemicals Pvt Ltd
07 1Srikem Laboratories Pvt. Ltd
08 1Symed Labs
09 1UCB Pharma S.A
10 1UQUIFA
01 1Belgium
02 4India
03 3Italy
04 1Spain
05 1U.S.A
01 3Active
02 4Inactive
03 3Blank
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01 1218MF11037
02 9Blank
01 10Blank
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GDUFA
DMF Review : Reviewed
Rev. Date : 2023-09-07
Pay. Date : 2023-07-27
DMF Number : 38535
Submission : 2023-07-03
Status : Active
Type : II
NDC Package Code : 66022-0122
Start Marketing Date : 2023-06-23
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-09-28
Pay. Date : 2013-09-24
DMF Number : 4514
Submission : 1982-04-16
Status : Active
Type : II
Registration Number : 218MF11037
Registrant's Address : Via Colleoni 15/17, 24040 Ciserano(BG)・Italy
Initial Date of Registration : 2006-12-28
Latest Date of Registration : --
NDC Package Code : 51604-0004
Start Marketing Date : 2009-10-14
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-09-04
Pay. Date : 2024-08-13
DMF Number : 36954
Submission : 2022-03-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4629
Submission : 1982-08-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3508
Submission : 1979-04-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 2808
Submission : 1976-11-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3695
Submission : 1980-01-16
Status : Inactive
Type : II
NDC Package Code : 49711-1508
Start Marketing Date : 2009-10-23
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 13746-111
Start Marketing Date : 2012-10-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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