01 1Aurobindo Pharma Limited
02 1Glenmark Life Sciences
03 1MSN Laboratories
04 1Synthetics China Company, Ltd.
05 1Teva API
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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