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01 1Evonik
02 1Ajinomoto Company
03 1Mitsubishi Tanabe Pharma
04 1SIGMA TAU
05 1Blank
01 5L-PROLINE
01 1Germany
02 2Japan
03 1U.S.A
04 1Blank
01 2Active
02 3Inactive
01 1Complete
02 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26400
Submission : 2012-09-03
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-08-27
Pay. Date : 2020-11-30
DMF Number : 31557
Submission : 2017-03-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10063
Submission : 1993-01-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3668
Submission : 1979-12-20
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1805
Submission : 1971-09-24
Status : Inactive
Type : II
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