01 1Fresenius Kabi AB Brunna
02 1Fresenius Kabi USA
03 1Kyongbo Pharmaceutical Co., Ltd
04 1Parabolic Drugs
05 1Penam Laboratories
06 1Pfizer Inc
01 2India
02 1South Korea
03 1Sweden
04 2U.S.A
01 2Inactive
02 4Blank
01 1Expired
02 1Valid
03 1Withdrawn by EDQM Failure to CEP procedure
04 3Blank
01 1221MF10291
02 5Blank
01 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13590
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17625
Submission : 2004-08-16
Status : Inactive
Type : II
Certificate Number : R0-CEP 2002-216 - Rev 01
Issue Date : 2004-11-18
Type : Chemical
Substance Number : 808
Status : Expired
Certificate Number : R0-CEP 2011-106 - Rev 00
Issue Date : 2012-10-11
Type : Chemical
Substance Number : 808
Status : Withdrawn by EDQM F...
Certificate Number : R1-CEP 2004-188 - Rev 06
Issue Date : 2022-10-10
Type : Chemical
Substance Number : 808
Status : Valid
Registration Number : 221MF10291
Registrant's Address : via Roma, n. 108 20060 Cassina de\' Pecchi (MI), Italy
Initial Date of Registration : 2009-12-25
Latest Date of Registration : --
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