01 1Amino Chemicals
02 1Apotex Pharmachem
03 1Aurobindo Pharma Limited
04 1Centaur Pharmaceuticals
05 1Chromo Laboratories
06 1Cipla
07 1Gador SA
08 1Guangzhou Tosun Pharmaceutical
09 1Jiangsu Nhwa Pharmaceutical
10 1Orchid Pharma
11 1Precise Group
12 1Teva API
13 1Teva Pharmaceutical Industries
14 1Zydus Lifesciences
01 1Argentina
02 1Canada
03 2China
04 7India
05 2Israel
06 1Malta
01 4Active
02 5Inactive
03 5Blank
01 14Blank
01 14Blank
01 1WC-0017
02 1WC-0107
03 1WC-0317
04 11Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19398
Submission : 2006-04-26
Status : Active
Type : II
Date of Issue : 2022-06-06
Valid Till : 2025-06-10
Written Confirmation Number : WC-0017
Address of the Firm :
NDC Package Code : 65862-197
Start Marketing Date : 2024-01-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
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Rev. Date :
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DMF Number : 17565
Submission : 2004-07-22
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-06-02
Pay. Date : 2013-09-25
DMF Number : 27568
Submission : 2013-09-25
Status : Active
Type : II
Date of Issue : 2022-06-08
Valid Till : 2025-06-25
Written Confirmation Number : WC-0107
Address of the Firm :
NDC Package Code : 64330-054
Start Marketing Date : 2018-01-05
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
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DMF Number : 20877
Submission : 2007-09-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 21482
Submission : 2008-04-01
Status : Inactive
Type : II
GDUFA
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Rev. Date :
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DMF Number : 18022
Submission : 2005-01-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 19015
Submission : 2005-12-13
Status : Inactive
Type : II
GDUFA
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DMF Number : 16785
Submission : 2003-08-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22572
Submission : 2009-02-25
Status : Inactive
Type : II
Date of Issue : 2022-02-02
Valid Till : 2024-06-07
Written Confirmation Number : WC-0317
Address of the Firm :
NDC Package Code : 52562-017
Start Marketing Date : 2021-06-19
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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