01 1Acebright India Pharma Private Limited
02 2Arene Lifesciences
03 2Aurobindo Pharma Limited
04 1Cipla
05 2Emcure Pharmaceuticals
06 4Hetero Drugs
07 2Laurus Labs
08 1Lupin Ltd
09 1Macleods Pharmaceuticals Limited
10 1RANBAXY LABORATORIES LIMITED
11 1SEQUENT SCIENTIFIC LTD
12 1SIBRA PHARMACEUTICALS LTD
13 1SMS Pharmaceuticals
14 1Shanghai Desano Bio-Pharmaceutical
15 5Viatris
16 1Zhejiang Huahai Pharmaceutical
17 1Zhejiang Jiangbei Pharmaceutical
01 5EFAVIRENZ
02 1EFAVIRENZ (ALTERNATE PROCESS)
03 1EFAVIRENZ (PROCESS I)
04 1EFAVIRENZ (PROCESS II)
05 1EFAVIRENZ (PROCESS III) USP
06 12EFAVIRENZ USP
07 1EFAVIRENZ USP (NON-STERILE DRUG SUBSTANCE)
08 1EFAVIRENZ USP (PROCESS - II)
09 1EFAVIRENZ USP (PROCESS-2)
10 1EFAVIRENZ USP (PROCESS-III)
11 1EFAVIRENZ USP (PROCESS-IV)
12 1EFAVIRENZ [DRUG SUBSTANCE (NON-STERILE)]
13 1EFAVIRENZ(FORM-H1)
01 3China
02 20India
03 5U.S.A
01 19Active
02 9Inactive
01 14Complete
02 14Blank
GDUFA
DMF Review : Complete
Rev. Date : 2013-12-17
Pay. Date : 2013-05-08
DMF Number : 24847
Submission : 2011-04-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19932
Submission : 2006-10-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-07-31
Pay. Date : 2015-07-28
DMF Number : 17802
Submission : 2004-10-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-31
Pay. Date : 2014-03-19
DMF Number : 20711
Submission : 2008-04-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-09
Pay. Date : 2012-12-21
DMF Number : 24943
Submission : 2011-05-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-26
Pay. Date : 2012-12-04
DMF Number : 20015
Submission : 2006-12-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-31
Pay. Date : 2013-01-11
DMF Number : 21964
Submission : 2008-09-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21666
Submission : 2008-05-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-27
Pay. Date : 2013-02-04
DMF Number : 23271
Submission : 2009-11-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-28
Pay. Date : 2013-08-20
DMF Number : 18230
Submission : 2005-03-30
Status : Active
Type : II
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