01 1Biotechnica DWC
02 1Boehringer Ingelheim GmbH
03 1Curia
04 1Farmitalia
05 1Medimpex
06 1TAPI Technology & API Services
07 1Teva Pharmaceutical Industries
01 1Algeria
02 1Germany
03 2Israel
04 1Italy
05 1U.S.A
06 1United Kingdom
01 2Active
02 4Inactive
03 1Blank
01 2Valid
02 1Withdrawn by Holder
03 4Blank
01 1220MF10122
02 6Blank
01 7Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-11-23
Pay. Date : 2012-11-08
DMF Number : 24782
Submission : 2011-03-23
Status : Active
Type : II
Certificate Number : R1-CEP 2007-328 - Rev 03
Issue Date : 2020-02-06
Type : Chemical
Substance Number : 224
Status : Valid
Registration Number : 220MF10122
Registrant's Address : Ostravska 305/29, Komarov, 747 70 Opava, Czech Republic
Initial Date of Registration : 2008-04-28
Latest Date of Registration : --
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-16
Pay. Date : 2013-12-02
DMF Number : 22932
Submission : 2009-07-06
Status : Active
Type : II
Certificate Number : R1-CEP 2008-291 - Rev 04
Issue Date : 2021-08-05
Type : Chemical
Substance Number : 224
Status : Valid
NDC Package Code : 55486-1581
Start Marketing Date : 2012-06-03
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3210
Submission : 1978-04-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3038
Submission : 1977-10-12
Status : Inactive
Type : II
NDC Package Code : 47848-001
Start Marketing Date : 2022-01-26
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3358
Submission : 1978-10-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5765
Submission : 1985-03-27
Status : Inactive
Type : II
Certificate Number : R0-CEP 2001-255 - Rev 01
Issue Date : 2004-10-13
Type : Chemical
Substance Number : 224
Status : Withdrawn by Holder
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