Neuland Laboratories- A dedicated 100% API provider.
01 1Neuland Laboratories
02 2Aurobindo Pharma Limited
03 2Changzhou Pharmaceutical Factory
04 3Glenmark Life Sciences
05 2Hetero Drugs
06 3Lupin Ltd
07 3MSN Laboratories
08 1Macleods Pharmaceuticals Limited
09 1Micro Labs Limited
10 1Raks Pharma
11 2Saptagir Laboratories
12 1Signa S.A. de C.V.
13 1Symed Labs
14 2Teva API
15 1Viatris
16 1WUHAN ZY PHARMACEUTICAL CO LTD
17 1Waterstone Pharmaceuticals Inc.
18 1Zhejiang Jingsheng Pharmaceutical
19 1Zhejiang Tianyu Pharmaceutical Co., Ltd
01 9EZETIMIBE
02 1EZETIMIBE (D067 PROCESS)
03 1EZETIMIBE (FORM-B)
04 1EZETIMIBE (PROCESS I)
05 1EZETIMIBE (ROUTE CODE: ZT)
06 1EZETIMIBE DRUG SUBSTANCE
07 1EZETIMIBE SILYLATED DIOL INTERMEDIATE (INTERMEDIATE OF EZETIMIBE)
08 7EZETIMIBE USP
09 1EZETIMIBE USP (FORM-X)
10 1EZETIMIBE USP (PROCESS-B)
11 1EZETIMIBE USP (PROCESS-C)
12 1EZETIMIBE USP (PROCESS-II)
13 1EZETIMIBE USP [ROUTE CODE "EE"]
14 1EZETIMIBE USP [ROUTE CODE - EB]
15 1EZETIMIBE USP [ROUTE CODE - EZ]
16 1EZETIMIBE, USP (PROCESS II)
01 6China
02 20India
03 2Israel
04 1Mexico
05 1U.S.A
01 27Active
02 3Inactive
01 20Complete
02 10Blank
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : Complete
Rev. Date : 2018-08-14
Pay. Date : 2018-07-05
DMF Number : 25543
Submission : 2011-11-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-04-03
Pay. Date : 2013-09-27
DMF Number : 24511
Submission : 2010-12-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-21
Pay. Date : 2013-11-29
DMF Number : 27303
Submission : 2013-09-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24825
Submission : 2011-04-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19717
Submission : 2006-08-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-06-14
Pay. Date : 2016-05-10
DMF Number : 26972
Submission : 2013-04-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-13
Pay. Date : 2013-08-01
DMF Number : 21554
Submission : 2008-04-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-06
Pay. Date : 2012-11-08
DMF Number : 26068
Submission : 2012-05-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-17
Pay. Date : 2013-04-04
DMF Number : 20039
Submission : 2006-12-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-01
Pay. Date : 2013-09-20
DMF Number : 25653
Submission : 2011-12-30
Status : Active
Type : II
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