01 1Aarti Drugs
02 3Cadila Pharmaceuticals
03 1Catalent Pharma Solutions
04 1Divis Laboratories
05 1Glenmark Life Sciences
06 1MERCK & CIE
07 1MSD INTL GMBH
08 2Morepen Laboratories
09 2Quimica Sintetica
10 1RANBAXY LABORATORIES LIMITED
11 1Rolabo Outsourcing
12 1Solara Active Pharma Sciences
13 2Vasudha Pharma Chem
14 2Viatris
15 1Zhejiang Wepon Pharmaceutical
16 3Zydus Lifesciences
17 1Blank
01 9LORATADINE
02 1LORATADINE (PROCESS 2) U.S.P.
03 1LORATADINE SOFTGELS (10 MG)
04 7LORATADINE USP
05 1LORATADINE USP (LCP)
06 1LORATADINE USP (LDP)
07 1LORATADINE USP (PROCESS-II)
08 1LORATADINE USP POWDER
09 2LORATIDINE
10 1LORATIDINE SPECIAL
01 1China
02 15India
03 1Singapore
04 3Spain
05 1Switzerland
06 3U.S.A
07 1Blank
01 14Active
02 11Inactive
01 7Complete
02 18Blank
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-21
Pay. Date : 2013-09-11
DMF Number : 17582
Submission : 2004-07-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19400
Submission : 2006-05-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6626
Submission : 1986-10-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-28
Pay. Date : 2013-09-24
DMF Number : 12650
Submission : 1997-09-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13032
Submission : 1998-06-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11803
Submission : 1995-12-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15251
Submission : 2001-01-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-05-26
Pay. Date : 2014-07-02
DMF Number : 14155
Submission : 1999-05-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-03-30
Pay. Date : 2014-10-10
DMF Number : 20367
Submission : 2007-03-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18702
Submission : 2005-08-25
Status : Active
Type : II
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