01 1Artemis Biotech
02 1Aurobindo Pharma Limited
03 2Biocon
04 1Glenmark Pharmaceuticals
05 2HEC Pharm
06 4HENAN TOPFOND PHARMACEUTICAL Co,. Ltd
07 2Hetero Drugs
08 1Jubilant Generics
09 2Krebs 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 2Sterling Biotech
17 2Teva API
18 1Viatris
19 1Zhejiang Apeloa Kangyu Pharmaceutical Co. Ltd
20 2Zhejiang Hisun Pharmaceutical
21 4Zhejiang Jiangbei Pharmaceutical
22 1Zhejiang Ruibang Laboratories
23 3Zydus Lifesciences
24 1Blank
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 AMMONIUM SALT (DRUG SUBSTANCE INTERMEDIATE)
11 2SIMVASTATIN AMMONIUM SALT (INTERMEDIATE)
12 1SIMVASTATIN AMMONIUM SALT(DRUG SUBSTANCE INTERMEDIATE)
13 1SIMVASTATIN NON-STERILE BULK DRUG SUBSTANCE
14 1SIMVASTATIN NON-STERILE DRUG SUBSTANCE, BULK FORM
15 12SIMVASTATIN USP
16 1SIMVASTATIN USP BULK
17 1SIMVASTATIN, NON-STERILE BULK FORM
18 1SIMVASTATIN, USP (PROCESS II)
01 16China
02 1Germany
03 17India
04 2Israel
05 1Slovenia
06 1Switzerland
07 1U.S.A
08 1Blank
01 15Active
02 25Inactive
01 9Complete
02 31Blank
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 : 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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 14599
Submission : 1999-11-29
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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