01 1Apotex Pharmachem
02 1Beijing Huikang Boyuan Chemical Tech CO.
03 1Cipla
04 1Fuxin Long Rui Pharmaceutical
05 1Hetero Drugs
06 1MSN Laboratories
07 2Morepen Laboratories
08 1Raks Pharma
09 1Teva Pharmaceutical Industries
10 1Viatris
11 1Wockhardt
01 1SAXAGLIPTIN HCI WITH MANNITOL COPRECIPITATE 20%
02 1SAXAGLIPTIN HCL
03 5SAXAGLIPTIN HYDROCHLORIDE
04 1SAXAGLIPTIN HYDROCHLORIDE (DIHYDRATE)
05 1SAXAGLIPTIN HYDROCHLORIDE (DIHYDRATE) [ROUTE CODE - "SH"]
06 2SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE
07 1SAXAGLIPTIN HYDROCHLORIDE PREMIX
01 1Canada
02 2China
03 7India
04 1Israel
05 1U.S.A
01 9Active
02 3Inactive
01 5Complete
02 7Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27201
Submission : 2013-07-05
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29299
Submission : 2015-05-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33486
Submission : 2019-07-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35690
Submission : 2021-02-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33635
Submission : 2019-02-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-19
Pay. Date : 2013-07-11
DMF Number : 27239
Submission : 2013-06-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-21
Pay. Date : 2013-06-10
DMF Number : 27189
Submission : 2013-06-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-04-02
Pay. Date : 2020-11-02
DMF Number : 34165
Submission : 2020-11-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-19
Pay. Date : 2013-06-04
DMF Number : 27146
Submission : 2013-06-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-19
Pay. Date : 2013-05-09
DMF Number : 27083
Submission : 2013-07-17
Status : Active
Type : II
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