01 2Chemtura Corporation US 06749 Middlebury
02 1IQT Industrias Quimicas Taubate
03 1MLA Group
04 1Mallinckrodt Pharmaceuticals
05 1Nitika Pharmaceutical Specialities
06 1SO.G.I.S Industria Chimica SpA IT 26048 Sospiro
07 1Skotmark Speciality Chemicals
08 1Blank
01 1Brazil
02 3India
03 1Ireland
04 1Italy
05 2U.S.A
06 1Blank
01 1Active
02 3Inactive
03 5Blank
01 4Valid
02 5Blank
01 9Blank
01 9Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35102
Submission : 2020-08-26
Status : Active
Type : IV
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 : 5877
Submission : 1985-05-06
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 : 27262
Submission : 2013-06-21
Status : Inactive
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2355
Submission : 1974-11-19
Status : Inactive
Type : II
Certificate Number : R1-CEP 2000-177 - Rev 01
Issue Date : 2006-11-15
Type : TSE
Substance Number : 882
Status : Valid
Certificate Number : R1-CEP 2001-006 - Rev 00
Issue Date : 2006-05-31
Type : TSE
Substance Number : 882
Status : Valid
Certificate Number : R1-CEP 2001-040 - Rev 01
Issue Date : 2022-03-03
Type : Chemical and TSE
Substance Number : 882
Status : Valid
Certificate Number : R1-CEP 2001-010 - Rev 00
Issue Date : 2007-01-25
Type : TSE
Substance Number : 2058
Status : Valid
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