01 1Taro Pharmaceutical Industries
02 1Chromo Laboratories
03 1Dishman Carbogen Amcis
04 1Divis Laboratories
05 1Glenmark Life Sciences
06 1Glenmark Pharmaceuticals
07 1Hetero Drugs
08 1Ipca Laboratories
09 1Jacobus Pharmaceutical Company, Inc
10 1National Institutes of Health
11 1Sifavitor srl
12 1Tianish Laboratories
13 1Viatris
14 1Zydus Lifesciences
01 9India
02 1Italy
03 4U.S.A
01 6Active
02 4Inactive
03 4Blank
01 4Valid
02 10Blank
01 14Blank
01 1WC-0031
02 1WC-0040
03 1WC-0091
04 1WC-0095
05 1WC-0137
06 1WC-0157
07 8Blank
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GDUFA
DMF Review : Reviewed
Rev. Date : 2015-02-23
Pay. Date : 2014-02-28
DMF Number : 26103
Submission : 2012-11-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 22059
Submission : 2008-10-06
Status : Active
Type : II
Date of Issue : 2019-10-11
Valid Till : 2022-07-02
Written Confirmation Number : WC-0157
Address of the Firm :
NDC Package Code : 65015-774
Start Marketing Date : 2015-02-19
End Marketing Date : 2026-12-01
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-09-05
Pay. Date : 2017-08-09
DMF Number : 24998
Submission : 2011-05-27
Status : Active
Type : II
Certificate Number : R1-CEP 2011-182 - Rev 00
Issue Date : 2018-08-20
Type : Chemical
Substance Number : 2002
Status : Valid
Date of Issue : 2022-07-04
Valid Till : 2025-07-03
Written Confirmation Number : WC-0040
Address of the Firm :
NDC Package Code : 65977-0071
Start Marketing Date : 2000-07-14
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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DMF Review : N/A
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DMF Number : 13857
Submission : 1998-11-23
Status : Inactive
Type : II
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DMF Number : 23270
Submission : 2009-11-16
Status : Inactive
Type : II
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DMF Review : N/A
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DMF Number : 21461
Submission : 2008-03-26
Status : Inactive
Type : II
Date of Issue : 2019-07-08
Valid Till : 2022-07-07
Written Confirmation Number : WC-0095
Address of the Firm :
GDUFA
DMF Review : N/A
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DMF Number : 34
Submission : 1946-12-13
Status : Inactive
Type : II
Date of Issue : 2016-07-19
Valid Till : 2019-07-02
Written Confirmation Number : WC-0137
Address of the Firm :
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