01 1Aurobindo Pharma Limited
02 1Glenmark Life Sciences
03 1MSN Laboratories
04 1Synthetics China Company, Ltd.
05 1TAPI Technology & API Services
06 1Zhejiang Supor Pharmaceuticals Co., LTD
01 1SAXAGLIPTIN
02 3SAXAGLIPTIN MONOHYDRATE
03 1SAXAGLIPTIN MONOHYDRATE (NON-STERILE DRUG SUBSTANCE)
04 1SAXAGLIPTIN MONOHYDRATE [ROUTE CODE - SC"]
01 2China
02 3India
03 1Israel
01 6Active
01 5Complete
02 1Blank
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-16
Pay. Date : 2013-05-07
DMF Number : 27111
Submission : 2013-05-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-14
Pay. Date : 2013-05-06
DMF Number : 26977
Submission : 2013-05-03
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-06-01
Pay. Date : 2017-05-18
DMF Number : 27309
Submission : 2013-07-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-08-01
Pay. Date : 2017-07-19
DMF Number : 31800
Submission : 2017-05-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-13
Pay. Date : 2013-06-17
DMF Number : 27174
Submission : 2013-06-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37169
Submission : 2022-05-30
Status : Active
Type : II
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