01 1CKD Bio Corporation
02 1Gujarat Themis Biosyn
03 1Luohe Chief Pharmaceutical
04 2Luohe Nanjiecun Pharmac. Group Pharmacy
05 2Lupin Ltd
06 2Olon S.p.A
07 1Prajna Generics
01 3China
02 4India
03 2Italy
04 1South Korea
01 9Active
02 1Blank
01 10Blank
01 10Blank
01 10Blank
GDUFA
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DMF Number : 35703
Submission : 2021-07-22
Status : Active
Type : II
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DMF Number : 11291
Submission : 1995-01-09
Status : Active
Type : II
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DMF Number : 22325
Submission : 2008-12-09
Status : Active
Type : II
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DMF Number : 28546
Submission : 2014-07-25
Status : Active
Type : II
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DMF Number : 35707
Submission : 2021-08-10
Status : Active
Type : II
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DMF Number : 32708
Submission : 2018-05-07
Status : Active
Type : II
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DMF Number : 32722
Submission : 2018-05-07
Status : Active
Type : II
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DMF Number : 26159
Submission : 2012-06-15
Status : Active
Type : II
NDC Package Code : 52972-0038
Start Marketing Date : 2012-06-21
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 : 38988
Submission : 2023-10-26
Status : Active
Type : II
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