01 2Alendronate Sodium
02 1Aminoimidazolecarboxamide Hydrochloride
03 1Benserazide Hydrochloride
04 1Bupropion Hydrobromide
05 2Bupropion Hydrochloride
06 1Diarachidonyl Phosphatidylcholine
07 1Diflunisal
08 2Dimyristoyl Lecithin
09 1Dimyristoylphosphatidylglycerol
10 1Eptifibatide
11 1Etodolac
12 1Fesoterodine
13 1Flunarizine
14 1Givinostat HCl
15 3Glycerylphosphorylcholine
16 1Goserelin Acetate
17 1Hydroxyzine Dihydrochloride
18 1Hydroxyzine Pamoate
19 1Ibandronate Sodium
20 1Indomethacin
21 1Leuprolide Acetate
22 3Mesalazine
23 1Miconazole
24 1Miconazole Nitrate
25 1Nabumetone
26 1Octreotide Acetate
27 1Oxiracetam
28 1Oxolinic Acid
29 1POPC
30 2POPG
31 1Paroxetine Hydrochloride
32 1Water
33 1Ypo0Ntk49O
34 1Zoledronic Acid
35 5Blank
01 11Active
02 29Inactive
03 7Blank
01 6Valid
02 2Withdrawn by Holder
03 39Blank
01 1219MF10131
02 1224MF10109
03 1224MF10177
04 1225MF10022
05 1226MF10055
06 42Blank
01 47Blank
01 120121228-168-I-169-04(1)
02 120121228-168-I-169-04(2)-A
03 120121228-168-I-169-04(3)
04 120230509-209-J-1430
05 43Blank
01 47Blank
01 15220
02 46Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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GDUFA
DMF Review : Reviewed
Rev. Date : 2014-10-20
Pay. Date : 2013-01-11
DMF Number : 14763
Submission : 2000-03-07
Status : Active
Type : II
Certificate Number : R1-CEP 2008-115 - Rev 04
Issue Date : 2022-03-10
Type : Chemical
Substance Number : 1442
Status : Valid
Registration Number : 224MF10177
Registrant's Address : Via dei Laboratori 54, 20092 Cinisello Balsamo (Milano), ITALY
Initial Date of Registration : 2012-08-17
Latest Date of Registration :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9454
Submission : 1991-12-09
Status : Inactive
Type : II
Certificate Number : R1-CEP 2008-046 - Rev 03
Issue Date : 2020-03-17
Type : Chemical
Substance Number : 1699
Status : Valid
Registration Number : 219MF10131
Registrant's Address : Via dei Laboratori 54, 20092 Cinisello Balsamo (Milano), ITALY
Initial Date of Registration : 2007-04-18
Latest Date of Registration :
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2023-05-09
Registration Number : 20230509-209-J-1430
Manufacturer Name : Chemi SpA
Manufacturer Address : Via Vadisi, 5-03010 Patrica (Frosinone) Italy
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-12-27
Pay. Date : 2012-11-19
DMF Number : 11951
Submission : 1996-04-29
Status : Active
Type : II
Certificate Number : R1-CEP 2003-188 - Rev 06
Issue Date : 2020-03-31
Type : Chemical
Substance Number : 1699
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12296
Submission : 1996-12-23
Status : Inactive
Type : II
Certificate Number : R1-CEP 2007-002 - Rev 01
Issue Date : 2014-03-10
Type : Chemical
Substance Number : 1350
Status : Withdrawn by Holder
Registration Number : 224MF10109
Registrant's Address : Viale dei Laboratori 54, 20092 Cinisello Balsamo (Milano), Italy
Initial Date of Registration : 2012-06-22
Latest Date of Registration :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 19567
Submission : 2006-06-28
Status : Active
Type : II
Registration Number : 226MF10055
Registrant's Address : Viale dei Laboratori 54, 20092 Cinisello Balsamo (Milano) ITALY
Initial Date of Registration : 2014-03-06
Latest Date of Registration :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25983
Submission : 2012-04-19
Status : Inactive
Type : II
Registration Number : 225MF10022
Registrant's Address : Viale dei Laboratori 54, 20092 Cinisello Balsamo (Milano), Italy
Initial Date of Registration : 2013-02-06
Latest Date of Registration :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14013
Submission : 1999-03-05
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2021-226 - Rev 02
Issue Date : 2025-02-10
Type : Chemical
Substance Number : 1173
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18922
Submission : 2005-10-27
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11834
Submission : 1996-01-29
Status : Active
Type : II
Italfarmaco S.p.a is a supplier offers 1 products (APIs, Excipients or Intermediates).
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