01 1B. Braun Medical
02 2Fresenius Kabi Austria
03 1Nitika Pharmaceutical Specialities
04 1S.A. Pharmachem
05 2Serumwerk Bernburg
06 1Blank
01 2Austria
02 2Germany
03 2India
04 1U.S.A
05 1Blank
01 1Active
02 2Inactive
03 5Blank
01 4Valid
02 4Blank
01 8Blank
01 8Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20879
Submission : 2007-09-21
Status : Active
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 : 6031
Submission : 1985-08-29
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 : 7074
Submission : 1987-06-30
Status : Inactive
Type : II
Certificate Number : R1-CEP 2014-281 - Rev 00
Issue Date : 2020-03-26
Type : Chemical
Substance Number : 1785
Status : Valid
Certificate Number : R1-CEP 2010-242 - Rev 00
Issue Date : 2017-06-29
Type : Chemical
Substance Number : 1785
Status : Valid
Certificate Number : R1-CEP 2010-284 - Rev 00
Issue Date : 2017-06-29
Type : Chemical
Substance Number : 1785
Status : Valid
Certificate Number : R1-CEP 2013-234 - Rev 00
Issue Date : 2019-06-21
Type : Chemical
Substance Number : 1785
Status : Valid
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