01 2Biocon
02 1CHONGQING ZEIN PHARMACEUTICAL CO LTD
03 1Divis Laboratories
04 1Formosa Laboratories
05 1Lunan Pharmaceutical
06 1Mcneil and Argus pharmaceuticals
07 2Murli Krishna Pharma
08 1RANBAXY LABORATORIES LIMITED
09 1Sun Pharmaceutical Industries Limited
10 2Zhejiang Hisun Pharmaceutical
01 6ORLISTAT
02 1ORLISTAT (NON-STERILE BULK)
03 2ORLISTAT PELLETS 50.0% W/W
04 4ORLISTAT USP
01 4China
02 8India
03 1Taiwan
01 9Active
02 4Inactive
01 4Complete
02 9Blank
GDUFA
DMF Review : Complete
Rev. Date : 2023-06-20
Pay. Date : 2023-05-11
DMF Number : 38096
Submission : 2023-04-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24885
Submission : 2011-04-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-06-30
Pay. Date : 2021-05-20
DMF Number : 35884
Submission : 2021-04-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-12
Pay. Date : 2013-08-29
DMF Number : 23978
Submission : 2010-07-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29914
Submission : 2015-10-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26455
Submission : 2012-09-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30780
Submission : 2016-08-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27624
Submission : 2013-09-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-03-22
Pay. Date : 2018-01-19
DMF Number : 32338
Submission : 2018-01-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22110
Submission : 2008-10-24
Status : Inactive
Type : II
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