01 1Asia Pioneer Pharmaceuticals
02 1Concord Biotech
03 1SAFC
04 1Sigma-Aldrich Corporation
05 1Zhejiang Hisun Pharmaceutical
01 1China
02 1India
03 3U.S.A
01 3Active
02 1Inactive
03 1Blank
01 5Blank
01 1221MF10187
02 4Blank
01 1WC-0111
02 4Blank
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GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-09
Pay. Date : 2012-12-18
DMF Number : 20658
Submission : 2007-06-20
Status : Active
Type : II
NDC Package Code : 58623-0098
Start Marketing Date : 2010-03-16
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Korea United Pharmaceutical Co., Ltd.
Registration Date : 2020-07-14
Registration Number : 20200714-210-J-490
Manufacturer Name : Zhejiang Hisun Pharmaceutical. Co., Ltd.
Manufacturer Address : No. 56 Binhai Road, Jiaojiang District, Taizhou City, Zhejiang China
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-02-04
Pay. Date : 2019-10-25
DMF Number : 34247
Submission : 2019-11-06
Status : Active
Type : II
Date of Issue : 2019-09-23
Valid Till : 2022-07-02
Written Confirmation Number : WC-0111
Address of the Firm :
NDC Package Code : 68254-0017
Start Marketing Date : 2016-05-16
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 : 3538
Submission : 1979-04-03
Status : Active
Type : II
Registration Number : 221MF10187
Registrant's Address : 13 Kiryat Mada Street, Har Hotzvim Industrial Park Jerusalem, 97770 ISRAEL
Initial Date of Registration : 2009-08-13
Latest Date of Registration : --
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13633
Submission : 1998-09-01
Status : Inactive
Type : II
NDC Package Code : 68305-200
Start Marketing Date : 1981-02-01
End Marketing Date : 2024-11-30
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
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