01 1BIOTIKA a.s.
02 2Bristol Myers Squibb
03 2Eli Lilly
04 1Fengchen Group
05 1Fermenta Biotech Limited
06 1Gurvey & Berry
07 1North China Pharmaceutical Huasheng Co Ltd
08 2Pfizer Inc
09 1Sandoz B2B
10 1Teva API
11 2Blank
01 1Canada
02 2China
03 1India
04 1Israel
05 1Slovakia
06 1Switzerland
07 6U.S.A
08 2Blank
01 2Active
02 10Inactive
03 3Blank
01 2Valid
02 1Withdrawn by EDQM Failure to CEP procedure
03 12Blank
01 15Blank
01 15Blank
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GDUFA
DMF Review : Reviewed
Rev. Date : 2018-01-26
Pay. Date : 2018-01-05
DMF Number : 13295
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : R2-CEP 1994-012 - Rev 06
Issue Date : 2017-05-15
Type : Chemical
Substance Number : 149
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13963
Submission : 1999-01-29
Status : Active
Type : II
Certificate Number : R1-CEP 1997-043 - Rev 02
Issue Date : 2008-02-08
Type : Chemical
Substance Number : 149
Status : Valid
NDC Package Code : 54563-002
Start Marketing Date : 2002-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13213
Submission : 1998-04-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13504
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13332
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13417
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13375
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13424
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13287
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13346
Submission : 1998-09-01
Status : Inactive
Type : II
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