01 1Chemische Fabrik Berg
02 1Herbrand PharmaChemicals GmbH
03 1Macleods Pharmaceuticals Limited
04 1Nantong Chem-land
05 1Nantong Jinghua Pharmaceutical
06 1Roche Diagnostics GmbH
07 1Sumitomo Chemical
08 1Suzhou Hengyi Pharmaceutical
09 1Suzhou Ryway Biotech
10 1Wanbang Biopharmaceuticals
11 1Blank
01 5China
02 3Germany
03 1India
04 1Japan
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01 3Active
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01 1Valid
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GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 16578
Submission : 2003-05-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
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DMF Number : 4928
Submission : 1983-03-22
Status : Active
Type : II
NDC Package Code : 20012-0001
Start Marketing Date : 2011-12-15
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-07-06
Pay. Date : 2015-05-12
DMF Number : 29101
Submission : 2015-04-28
Status : Active
Type : II
Certificate Number : CEP 2015-125 - Rev 01
Issue Date : 2023-10-02
Type : Chemical
Substance Number : 525
Status : Valid
Date of Issue : 2019-11-28
Valid Till : 2022-07-02
Written Confirmation Number : WC-0079
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GDUFA
DMF Review : N/A
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DMF Number : 8377
Submission : 1990-01-15
Status : Inactive
Type : II
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GDUFA
DMF Review : N/A
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DMF Number : 8278
Submission : 1989-10-03
Status : Inactive
Type : II
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NDC Package Code : 59348-0013
Start Marketing Date : 2019-01-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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