01 1Artemis Biotech
02 1Aurobindo Pharma Limited
03 2Biocon
04 1Glenmark Pharmaceuticals
05 2HEC Pharm
06 2HENAN TOPFOND PHARMACEUTICAL Co,. Ltd
07 2Hetero Drugs
08 1Jubilant Generics
09 1Krebs Biochemicals & Industries Ltd
10 1Lek Pharmaceuticals
11 1Lupin Ltd
12 1RANBAXY LABORATORIES LIMITED
13 1SYNTHON Chemicals GmbH & Co. KG
14 1Sandoz B2B
15 2Southwest Synthetic Pharmaceutical
16 1Sterling Biotech
17 2TAPI Technology & API Services
18 1Viatris
19 1Zhejiang Apeloa Kangyu Pharmaceutical Co. Ltd
20 2Zhejiang Hisun Pharmaceutical
21 5Zhejiang Jiangbei Pharmaceutical
22 1Zhejiang Ruibang Laboratories
23 3Zydus Lifesciences
01 10SIMVASTATIN
02 1SIMVASTATIN (DRUG SUBSTANCE)
03 1SIMVASTATIN ( LOVASTATIN ROUTE)
04 1SIMVASTATIN (AMMONIUM SALT ROUTE)
05 1SIMVASTATIN (BHA ADDED) USP
06 1SIMVASTATIN (ETHANOL PROCESS)
07 1SIMVASTATIN (WITH 0.01% BHA)
08 2SIMVASTATIN AMMONIUM SALT
09 1SIMVASTATIN AMMONIUM SALT (ALTERNATIVE PROCESS)
10 1SIMVASTATIN NON-STERILE BULK DRUG SUBSTANCE
11 1SIMVASTATIN NON-STERILE DRUG SUBSTANCE, BULK FORM
12 12SIMVASTATIN USP
13 1SIMVASTATIN USP BULK
14 1SIMVASTATIN, NON-STERILE BULK FORM
15 1SIMVASTATIN, USP (PROCESS II)
01 15China
02 1Germany
03 15India
04 2Israel
05 1Slovenia
06 1Switzerland
07 1U.S.A
01 13Active
02 23Inactive
01 9Complete
02 27Blank
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-15
Pay. Date : 2013-03-01
DMF Number : 18449
Submission : 2005-06-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19545
Submission : 2006-04-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-12-05
Pay. Date : 2013-07-05
DMF Number : 27231
Submission : 2013-06-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18755
Submission : 2005-09-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-17
Pay. Date : 2017-02-28
DMF Number : 17934
Submission : 2004-12-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-18
Pay. Date : 2013-09-23
DMF Number : 23425
Submission : 2009-12-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14599
Submission : 1999-11-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-13
Pay. Date : 2012-11-13
DMF Number : 25024
Submission : 2011-06-08
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-29
Pay. Date : 2012-11-15
DMF Number : 16305
Submission : 2002-12-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-20
Pay. Date : 2016-09-26
DMF Number : 26971
Submission : 2013-03-04
Status : Active
Type : II
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