01 1Biocon
02 1BrightGene Bio-Medical Technology Co.,Ltd
03 1Guangdong Newdarin Biotechnology
04 1JIAOZUO JOINCARE BIOTECHNOLOGICAL CO LTD
05 1Partner Therapeutics
06 2Shanghai Techwell Biopharma.Co., Ltd.
07 1Yacht Bio-Technology
08 1Zhejiang Hisun Pharmaceutical
09 1Zhejiang Huida Biotech
01 8China
02 1India
03 1U.S.A
01 4Active
02 4Inactive
03 2Blank
01 10Blank
01 10Blank
01 10Blank
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 32798
Submission : 2018-04-27
Status : Active
Type : II
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DMF Review : N/A
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DMF Number : 25728
Submission : 2011-01-19
Status : Active
Type : II
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DMF Number : 35248
Submission : 2020-09-30
Status : Active
Type : II
NDC Package Code : 78772-001
Start Marketing Date : 2021-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34006
Submission : 2019-07-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27218
Submission : 2013-06-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29552
Submission : 2015-08-31
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29681
Submission : 2015-10-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29289
Submission : 2015-04-05
Status : Inactive
Type : II
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