01 1Chromo Laboratories
02 1Dishman Carbogen Amcis
03 1Divis Laboratories
04 1Glenmark Life Sciences
05 1Glenmark Pharmaceuticals
06 1Hetero Drugs
07 1Ipca Laboratories
08 1Jacobus Pharmaceutical Company, Inc
09 1National Institutes of Health
10 1Sifavitor srl
11 1Taro Pharmaceutical Industries
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-0137
05 1WC-0157
06 9Blank
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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 :
Pay. Date :
DMF Number : 32644
Submission : 2018-03-30
Status : Active
Type : II
NDC Package Code : 66039-942
Start Marketing Date : 2018-03-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-12-05
Pay. Date : 2013-07-30
DMF Number : 21475
Submission : 2008-06-16
Status : Active
Type : II
Certificate Number : R1-CEP 2008-180 - Rev 03
Issue Date : 2021-12-06
Type : Chemical
Substance Number : 2002
Status : Valid
Date of Issue : 2022-06-08
Valid Till : 2025-07-02
Written Confirmation Number : WC-0091
Address of the Firm :
NDC Package Code : 57451-1162
Start Marketing Date : 2012-02-23
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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 : 2014-12-16
Pay. Date : 2014-12-08
DMF Number : 18065
Submission : 2005-02-06
Status : Active
Type : II
Certificate Number : R1-CEP 2010-362 - Rev 02
Issue Date : 2018-02-28
Type : Chemical
Substance Number : 2002
Status : Valid
Date of Issue : 2022-06-16
Valid Till : 2025-06-16
Written Confirmation Number : WC-0031
Address of the Firm :
NDC Package Code : 62331-023
Start Marketing Date : 2004-05-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 13857
Submission : 1998-11-23
Status : Inactive
Type : II
GDUFA
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Rev. Date :
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DMF Number : 23270
Submission : 2009-11-16
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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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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