01 1Abbott Laboratories
02 1Alembic Pharmaceuticals Limited
03 2Biocon
04 3Chongqing DaXin Pharmaceutical
05 1Concord Biotech
06 2Ercros
07 1Krebs Biochemicals & Industries Ltd
08 2Lek Pharmaceuticals
09 1Livzon New North River Pharmaceutical
10 3Lupin Ltd
11 1Merck & Co
12 2RANBAXY LABORATORIES LIMITED
13 2Recordati
14 1Sandoz B2B
15 1Sterling Biotech
16 1Syngen Biotech
17 1Teva API
18 1Yung Shin Pharmaceutical Industrial
19 1Zhejiang Apeloa Kangyu Pharmaceutical Co. Ltd
20 1Zhejiang Hisun Pharmaceutical
21 2Zhejiang Ruibang Laboratories
01 10LOVASTATIN
02 1LOVASTATIN (NON-STERILE, BULK FORM)
03 1LOVASTATIN (TECHNICAL GRADE)
04 1LOVASTATIN ACTIVE DRUG SUBSTANCE
05 1LOVASTATIN DRUG SUBSTANCE INTERMEDIATE
06 1LOVASTATIN TECHNICAL
07 1LOVASTATIN TECHNICAL(SFP)
08 9LOVASTATIN USP
09 1LOVASTATIN USP, NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT
10 1LOVASTATIN(API)
11 2LOVASTATIN, USP
12 1LOVASTATION USP
13 1MK-803 (MEVINOLIN) AS SYNTHESIZED-PILOT PREPARATION OF RAHWAY NJ PLANT
01 10China
02 11India
03 1Israel
04 2Italy
05 2Slovenia
06 2Spain
07 1Switzerland
08 2U.S.A
01 11Active
02 20Inactive
01 2Complete
02 29Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14912
Submission : 2000-06-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20061
Submission : 2006-12-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17393
Submission : 2004-05-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18539
Submission : 2005-07-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17353
Submission : 2004-04-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17737
Submission : 2004-09-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24859
Submission : 2011-04-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-27
Pay. Date : 2012-12-03
DMF Number : 11502
Submission : 1995-05-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19217
Submission : 2006-03-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-26
Pay. Date : 2012-11-15
DMF Number : 12133
Submission : 1996-09-17
Status : Active
Type : II
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