01 1Cilag AG
02 1Erregierre SpA
03 2Industriale Chimica
04 1Jiangsu Lianhuan Pharmaceutical
05 1Procos
06 1Quimica Sintetica
07 1RANBAXY LABORATORIES LIMITED
08 1Recipharm AB
09 1Recordati
10 1TAPI Technology & API Services
11 3Blank
01 1China
02 1India
03 1Israel
04 5Italy
05 1Spain
06 1Sweden
07 1Switzerland
08 3Blank
01 12Inactive
02 2Blank
01 1Expired
02 13Blank
01 14Blank
01 14Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9525
Submission : 1992-02-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8238
Submission : 1989-10-05
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9038
Submission : 1991-03-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8990
Submission : 1991-02-27
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4768
Submission : 1982-12-16
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8455
Submission : 1990-02-15
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9292
Submission : 1991-08-02
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8398
Submission : 1990-01-25
Status : Inactive
Type : II
Certificate Number : R1-CEP 1997-010 - Rev 01
Issue Date : 2004-10-28
Type : Chemical
Substance Number : 955
Status : Expired
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