Inke S.A: APIs manufacturing plant.
01 1Inke S.A
02 1Neuland Laboratories
03 1TAPI Technology & API Services
04 1Alkem Laboratories
05 3Apotex Pharmachem
06 2Aurobindo Pharma Limited
07 1Cadila Pharmaceuticals
08 1Chromo Laboratories
09 2Cipla
10 1HEC Pharm
11 2Hansoh Pharma
12 1Hetero Drugs
13 1Ipca Laboratories
14 2Jubilant Generics
15 1Kyongbo Pharmaceutical Co., Ltd
16 1Lee Pharma
17 1Lek Pharmaceuticals
18 1Macleods Pharmaceuticals Limited
19 1Orchid Pharma
20 1Qilu Pharmaceutical
21 1RANBAXY LABORATORIES LIMITED
22 1Solara Active Pharma Sciences
23 1Sun Pharmaceutical Industries Limited
24 1Torrent Pharmaceuticals Limited
25 1Venkat Pharma
26 1Viatris
27 1Zhejiang Hisun Pharmaceutical
28 1Zhejiang Supor Pharmaceuticals Co., LTD
29 2Zydus Lifesciences
01 11OLANZAPINE
02 1OLANZAPINE (FORM-1)
03 1OLANZAPINE (FORM-I)
04 1OLANZAPINE DRUG SUBSTANCE
05 1OLANZAPINE FORM II USP
06 1OLANZAPINE FORM-1 USP
07 1OLANZAPINE FORM-I USP
08 2OLANZAPINE NON-STERILE BULK DRUG SUBSTANCE
09 13OLANZAPINE USP
10 1OLANZAPINE USP (CRYSTALLINE POLYMORPH FORM-II)
11 1OLANZAPINE USP (FORM-I)
12 1OLANZAPINE USP (NON-STERILE DRUG SUBSTANCE)
13 1OLANZAPINE USP, NON-STERILE
01 3Canada
02 6China
03 1Iceland
04 21India
05 1Israel
06 1Slovenia
07 1South Korea
08 1Spain
09 1U.S.A
01 25Active
02 11Inactive
01 15Complete
02 21Blank
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-03
Pay. Date : 2013-01-23
DMF Number : 26694
Submission : 2013-01-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19282
Submission : 2006-03-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-18
Pay. Date : 2014-02-10
DMF Number : 20218
Submission : 2007-01-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-29
Pay. Date : 2013-09-20
DMF Number : 21980
Submission : 2008-09-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-02-13
Pay. Date : 2013-09-11
DMF Number : 22301
Submission : 2008-12-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-24
Pay. Date : 2013-12-10
DMF Number : 20591
Submission : 2007-06-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-23
Pay. Date : 2012-12-17
DMF Number : 20990
Submission : 2007-10-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-07-13
Pay. Date : 2021-07-09
DMF Number : 18260
Submission : 2005-04-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21506
Submission : 2008-03-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22555
Submission : 2009-02-18
Status : Active
Type : II
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