01 1CARBOGEN AMCIS AG
02 1Catalent Pharma Solutions
03 1DISHMAN NETHERLANDS B.V.
04 1Dishman Carbogen Amcis
05 1DongWha Pharm
06 1Formosa Laboratories
07 1Hanways Chempharm
08 1Haoyuan Chemexpress Co.Ltd
09 2Lukasiewicz Industrial Chemistry Institute
10 1SOLVAY -Technology Solutions
11 1Zhejiang Ausun Pharmaceutical
01 3China
02 1Germany
03 1India
04 1Netherlands
05 2Poland
06 1South Korea
07 1Switzerland
08 1Taiwan
09 1U.S.A
01 2Active
02 2Inactive
03 8Blank
01 3Valid
02 1Withdrawn by Holder
03 8Blank
01 12Blank
01 12Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33640
Submission : 2019-05-03
Status : Active
Type : II
Certificate Number : CEP 2019-163 - Rev 02
Issue Date : 2024-08-27
Type : Chemical
Substance Number : 1295
Status : Valid
NDC Package Code : 66499-0065
Start Marketing Date : 2019-09-06
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-07-28
Pay. Date : 2016-07-08
DMF Number : 21963
Submission : 2008-09-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15564
Submission : 2001-08-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12386
Submission : 1997-02-27
Status : Inactive
Type : II
Certificate Number : R1-CEP 1998-059 - Rev 08
Issue Date : 2022-01-07
Type : Chemical and TSE
Substance Number : 1295
Status : Valid
NDC Package Code : 45408-002
Start Marketing Date : 2012-08-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Certificate Number : R0-CEP 2022-335 - Rev 00
Issue Date : 2022-11-29
Type : Chemical
Substance Number : 1295
Status : Valid
Certificate Number : R0-CEP 2015-359 - Rev 01
Issue Date : 2022-08-09
Type : Chemical
Substance Number : 1295
Status : Withdrawn by Holder
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