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01 1Fermion Oy
02 1Asymchem Laboratories
03 1Fuan Pharmaceutical
04 1Guangzhou Tosun Pharmaceutical
05 1MSN Laboratories
06 2Olon S.p.A
07 1Tai Heng Industry Co., Ltd
01 3China
02 1Finland
03 1India
04 2Italy
05 1U.S.A
01 5Active
02 1Inactive
03 2Blank
01 8Blank
01 1222MF10048
02 1225MF10098
03 6Blank
01 1WC-0349
02 7Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6652
Submission : 1986-08-08
Status : Active
Type : II
Registration Number : 222MF10048
Registrant's Address : Koivu-Mankkaan tie 6A, FI-02200 Espoo, Finland
Initial Date of Registration : 2010-02-09
Latest Date of Registration : --
| Available Reg Filing : ASMF |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34142
Submission : 2019-10-28
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-04-12
Pay. Date : 2019-01-28
DMF Number : 33128
Submission : 2018-08-31
Status : Active
Type : II
Date of Issue : 2022-09-02
Valid Till : 2025-05-05
Written Confirmation Number : WC-0349
Address of the Firm :
NDC Package Code : 54893-0079
Start Marketing Date : 2018-08-31
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 : 24407
Submission : 2010-11-17
Status : Active
Type : II
NDC Package Code : 17337-0305
Start Marketing Date : 2010-08-10
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-02-05
Pay. Date : 2015-07-16
DMF Number : 28770
Submission : 2014-10-16
Status : Active
Type : II
NDC Package Code : 17337-0305
Start Marketing Date : 2010-08-10
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 : 30640
Submission : 2016-06-21
Status : Inactive
Type : II
Registration Number : 225MF10098
Registrant's Address : 366 Anping Road, Zhaobaoshan Street, Zhenhai District, Ningbo City, Zhejiang Province, P. R. of China
Initial Date of Registration : 2013-05-09
Latest Date of Registration : --
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