01 2ACS DOBFAR SPA
02 1Antibioticos do Brasil Ltda
03 1Aurobindo Pharma Limited
04 1China Union Chempharma (Suzhou) Co.,Ltd
05 1Freemen Nutra
06 1Fresenius Kabi AB Brunna
07 1Fresenius Kabi Anti-Infectives
08 1Grand Health Industrial Co Ltd
09 1Guangzhou Tosun Pharmaceutical
10 1Hainan Haiyao
11 1Kaliberr Labs
12 1Nectar Lifesciences
13 1Orchid Pharma
01 1Brazil
02 5China
03 4India
04 3Italy
05 1Sweden
01 2Active
02 4Inactive
03 8Blank
01 1Expired
02 1Valid
03 1Withdrawn by Holder
04 11Blank
01 14Blank
01 1WC-0131
02 13Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18149
Submission : 2005-03-08
Status : Active
Type : II
Certificate Number : CEP 2005-108 - Rev 06
Issue Date : 2024-09-09
Type : Chemical
Substance Number : 990
Status : Valid
Date of Issue : 2019-07-22
Valid Till : 2022-07-21
Written Confirmation Number : WC-0131
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12976
Submission : 1998-04-30
Status : Active
Type : II
NDC Package Code : 52946-0828
Start Marketing Date : 2009-12-09
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 : 20698
Submission : 2007-07-16
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19789
Submission : 2006-09-19
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21329
Submission : 2008-01-31
Status : Inactive
Type : II
Certificate Number : R0-CEP 2008-015 - Rev 01
Issue Date : 2013-06-10
Type : Chemical
Substance Number : 990
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20635
Submission : 2007-06-20
Status : Inactive
Type : II
NDC Package Code : 52946-0828
Start Marketing Date : 2009-12-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Certificate Number : R0-CEP 2007-173 - Rev 01
Issue Date : 2013-04-24
Type : Chemical
Substance Number : 990
Status : Expired
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