01 2Abbott Laboratories
02 2DANIPHARM A S
03 1Fresenius Kabi AB Brunna
04 5Fresenius Kabi Austria
05 1Fresenius Kabi USA
06 1Guangzhou Tosun Pharmaceutical
07 1Harman Finochem
08 4Inalco SpA
09 1Lactose India Limited
10 1Milei GmbH DE 70191 Stuttgart
11 1RELAX LTD
12 1Relax Limited
13 2SCM Pharma
14 3SOLVAY -Technology Solutions
15 1Syngars Technology
16 1Zambon Switzerland
17 1Zhejiang Tiantai Pharmaceutical
18 2Blank
01 5Austria
02 3China
03 2Denmark
04 4Germany
05 2India
06 4Italy
07 2Malta
08 1Sweden
09 1Switzerland
10 3U.S.A
11 2United Kingdom
12 2Blank
01 9Active
02 11Inactive
03 11Blank
01 1Expired
02 10Valid
03 1Withdrawn by EDQM Failure to CEP procedure
04 1Withdrawn by Holder
05 18Blank
01 1217MF11291
02 1217MF11292
03 1219MF10056
04 1222MF10224
05 27Blank
01 31Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5412
Submission : 1984-02-07
Status : Active
Type : II
Certificate Number : R0-CEP 2019-324 - Rev 00
Issue Date : 2020-05-19
Type : Chemical and TSE
Substance Number : 924
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-09-09
Pay. Date : 2014-12-12
DMF Number : 15253
Submission : 2001-02-16
Status : Active
Type : II
Certificate Number : R1-CEP 2015-187 - Rev 00
Issue Date : 2020-10-30
Type : Chemical
Substance Number : 924
Status : Valid
NDC Package Code : 18124-007
Start Marketing Date : 2022-05-12
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1250kg/1250kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-03-15
Pay. Date : 2013-03-04
DMF Number : 8195
Submission : 1989-09-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39039
Submission : 2024-01-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 835
Submission : 1964-09-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11448
Submission : 1995-04-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12699
Submission : 1997-10-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7682
Submission : 1988-09-20
Status : Inactive
Type : II
Certificate Number : R1-CEP 1999-145 - Rev 02
Issue Date : 2014-05-13
Type : Chemical
Substance Number : 924
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9537
Submission : 1992-01-30
Status : Inactive
Type : II
Certificate Number : R0-CEP 2001-238 - Rev 01
Issue Date : 2004-11-15
Type : Chemical
Substance Number : 1230
Status : Expired
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11262
Submission : 1994-12-25
Status : Inactive
Type : II
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