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01 1Fermion Oy
02 1ASG Biochem
03 1Cambrex Corporation
04 1Glenmark Life Sciences
05 1Guangzhou Tosun Pharmaceutical
06 1HONOUR LAB LTD
07 1Hangzhou Longshine Bio-Tech
08 1Hetero Drugs
09 1Maithri Drugs
10 1Olon S.p.A
11 1Shionogi
12 1Tianjin Weijie Pharmaceutical Co., Ltd.
01 3China
02 1Finland
03 5India
04 1Italy
05 1Japan
06 1U.S.A
01 8Active
02 4Blank
01 12Blank
01 12Blank
01 1WC-0310
02 11Blank
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GDUFA
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DMF Number : 25541
Submission : 2011-11-30
Status : Active
Type : II
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DMF Number : 30474
Submission : 2016-06-13
Status : Active
Type : II
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DMF Number : 38660
Submission : 2023-07-31
Status : Active
Type : II
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DMF Review : Reviewed
Rev. Date : 2016-12-07
Pay. Date : 2016-09-07
DMF Number : 30858
Submission : 2016-10-17
Status : Active
Type : II
NDC Package Code : 69037-0026
Start Marketing Date : 2013-02-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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DMF Number : 31163
Submission : 2018-12-17
Status : Active
Type : II
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DMF Number : 35877
Submission : 2021-07-29
Status : Active
Type : II
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