01 1American Pacific Corporation
02 1Azico Biophore India Pvt. Ltd
03 1BrightGene Bio-Medical Technology Co.,Ltd
04 1Chromo Laboratories
05 1Cipla
06 1HEC Pharm
07 1Hetero Drugs
08 1Innovare Labs
09 1Laurus Labs
10 1Lupin Ltd
11 2MSN Laboratories
12 1Macleods Pharmaceuticals Limited
13 1Raks Pharma
14 1Shanghai Desano Chemical Pharmaceutical Co., Ltd.
15 2Sinopep Pharmaceutical Inc
16 1Solara Active Pharma Sciences
17 1Viatris
18 1Zhejiang Huahai Pharmaceutical
19 1Zydus Lifesciences
01 1OSELTAMIVIR INTERMEDIATE (CAS No.: 651324-08-2)
02 7OSELTAMIVIR PHOSPHATE
03 1OSELTAMIVIR PHOSPHATE DRUG SUBSTANCE
04 1OSELTAMIVIR PHOSPHATE NON-STERILE BULK DRUG SUBSTANCE
05 10OSELTAMIVIR PHOSPHATE USP
06 1OSELTAMIVIR PHOSPHATE [ROUTE CODE - "OT"]
01 6China
02 13India
03 2U.S.A
01 21Active
01 16Complete
02 5Blank
GDUFA
DMF Review : Complete
Rev. Date : 2021-11-19
Pay. Date : 2021-09-30
DMF Number : 21557
Submission : 2008-05-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-07-19
Pay. Date : 2016-05-03
DMF Number : 30412
Submission : 2016-03-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-01-24
Pay. Date : 2019-11-13
DMF Number : 33767
Submission : 2020-01-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-07-06
Pay. Date : 2016-04-08
DMF Number : 30253
Submission : 2016-04-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-25
Pay. Date : 2013-09-23
DMF Number : 27533
Submission : 2013-09-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-16
Pay. Date : 2014-04-25
DMF Number : 23889
Submission : 2010-06-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-01-09
Pay. Date : 2018-11-27
DMF Number : 33373
Submission : 2018-11-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-03-01
Pay. Date : 2020-09-28
DMF Number : 33907
Submission : 2020-04-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-10-21
Pay. Date : 2015-09-08
DMF Number : 22926
Submission : 2009-07-08
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-08-27
Pay. Date : 2016-06-17
DMF Number : 30012
Submission : 2015-11-30
Status : Active
Type : II
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