01 1Arch Pharmalabs
02 4Aurobindo Pharma Limited
03 2Cipla
04 2Hetero Drugs
05 1MATRIX LABORATORIES XIAMEN LTD.
06 1Matrix Pharmaceutical Inc
07 1RANBAXY LABORATORIES LIMITED
08 1SEQUENT SCIENTIFIC LTD
09 1Shanghai Desano Bio-Pharmaceutical
10 1Tyche Industries Ltd
11 3Viatris
12 1Zhejiang Huahai Pharmaceutical
01 2NEVIRAPINE
02 2NEVIRAPINE ANHYDROUS
03 4NEVIRAPINE ANHYDROUS USP
04 1NEVIRAPINE ANHYDROUS USP (PROCESS II)
05 3NEVIRAPINE HEMIHYDRATE USP
06 3NEVIRAPINE USP
07 1NEVIRAPINE USP (ANHYDROUS)
08 1NEVIRAPINE USP (ANHYDROUS) (NON-STERILE BULK) DRUG SUBSTANCE
09 1NEVIRAPINE USP (ANHYDROUS) (RAN)
10 1NEVIRAPINE USP, NON-STERILE BULK FORM
01 3China
02 12India
03 4U.S.A
01 11Active
02 8Inactive
01 8Complete
02 11Blank
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-05
Pay. Date : 2014-06-03
DMF Number : 18576
Submission : 2005-07-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18401
Submission : 2005-05-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17851
Submission : 2004-11-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-05-01
Pay. Date : 2015-04-09
DMF Number : 24520
Submission : 2011-01-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-14
Pay. Date : 2013-11-21
DMF Number : 17905
Submission : 2004-12-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-23
Pay. Date : 2014-04-16
DMF Number : 19753
Submission : 2008-04-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17782
Submission : 2004-10-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-15
Pay. Date : 2013-01-24
DMF Number : 21280
Submission : 2008-01-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-21
Pay. Date : 2013-05-10
DMF Number : 17915
Submission : 2004-12-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-08
Pay. Date : 2012-12-07
DMF Number : 19712
Submission : 2006-08-11
Status : Active
Type : II
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