01 1Amsa Spa
02 1DEAFARMA
03 1Daito Pharmaceutical
04 1Edmond Pharma
05 1Kanto Chemical
06 1Lusochimica
07 1Otsuka Chemical Co Ltd
08 1Recipharm AB
09 1Stellence Pharmscience
01 2India
02 3Italy
03 3Japan
04 1Sweden
01 1Active
02 3Inactive
03 5Blank
01 1Valid
02 1Withdrawn by Holder
03 7Blank
01 1219MF10024
02 1221MF10036
03 7Blank
01 9Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12509
Submission : 1997-05-15
Status : Active
Type : II
Certificate Number : R1-CEP 2005-199 - Rev 01
Issue Date : 2022-10-10
Type : Chemical
Substance Number : 1972
Status : Valid
NDC Package Code : 43898-0104
Start Marketing Date : 1997-05-15
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2008-03-31
Registration Number : 20080331-87-D-48-03
Manufacturer Name : Lusochimica SpA
Manufacturer Address : Via Giotto 9, 23871 Lomagna(LC),Itlay
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14946
Submission : 2000-07-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12714
Submission : 1997-10-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2671
Submission : 1976-05-13
Status : Inactive
Type : II
Registration Number : 221MF10036
Registrant's Address : 3-2-8 Nihonbashi Honcho, Chuo-ku, Tokyo
Initial Date of Registration : 2009-02-09
Latest Date of Registration : --
Registration Number : 219MF10024
Registrant's Address : 326 Yokamachi, Toyama City, Toyama Prefecture
Initial Date of Registration : 2007-01-22
Latest Date of Registration : --
Certificate Number : R1-CEP 2002-228 - Rev 03
Issue Date : 2015-04-24
Type : Chemical
Substance Number : 1972
Status : Withdrawn by Holder
Registrant Name : Samchundang Pharmaceutical Co., Ltd.
Registration Date : 2011-10-21
Registration Number : 20080507-87-D-44-04(2)
Manufacturer Name : EDMOND PHARMA Srl
Manufacturer Address : Via dei Giovi 131 20037 Paderno Dugnano (MI), Italy
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