01 2Alembic Pharmaceuticals Limited
02 1Gilead Sciences
03 1HONOUR LAB LTD
04 1Hetero Drugs
05 2MSN Laboratories
06 1Mangalam Drugs & Organics Ltd
07 1Prague Scientific
08 1Shanghai Desano Chemical Pharmaceutical Co., Ltd.
09 1Sun-shine Chem
10 2Viatris
11 1Zhejiang Ausun Pharmaceutical
01 3China
02 1Czech Republic
03 7India
04 3U.S.A
01 7Active
02 7Blank
01 14Blank
01 14Blank
01 1WC-0082
02 1WC-0082A11
03 1WC-0362
04 1WC-0383A4
05 10Blank
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GDUFA
DMF Review : Reviewed
Rev. Date : 2017-01-08
Pay. Date : 2016-09-29
DMF Number : 30772
Submission : 2016-08-30
Status : Active
Type : II
Date of Issue : 2019-10-15
Valid Till : 2022-08-08
Written Confirmation Number : WC-0383A4
Address of the Firm :
NDC Package Code : 69766-015
Start Marketing Date : 2016-07-28
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 : 31090
Submission : 2016-12-27
Status : Active
Type : II
NDC Package Code : 69766-015
Start Marketing Date : 2016-07-28
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 : 32456
Submission : 2017-12-20
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-03-31
Pay. Date : 2013-12-09
DMF Number : 27727
Submission : 2013-12-27
Status : Active
Type : II
NDC Package Code : 65015-839
Start Marketing Date : 2015-03-03
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-10-22
Pay. Date : 2015-07-28
DMF Number : 29558
Submission : 2015-08-28
Status : Active
Type : II
NDC Package Code : 65015-839
Start Marketing Date : 2015-03-03
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 : 34649
Submission : 2020-03-30
Status : Active
Type : II
Date of Issue : 2022-06-17
Valid Till : 2025-07-02
Written Confirmation Number : WC-0082
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25187
Submission : 2011-10-21
Status : Active
Type : II
Date of Issue : 2019-07-26
Valid Till : 2022-05-05
Written Confirmation Number : WC-0362
Address of the Firm :
NDC Package Code : 69037-0002
Start Marketing Date : 2012-08-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2021-10-05
Valid Till : 2022-07-02
Written Confirmation Number : WC-0082A11
Address of the Firm :
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