01 1Aurobindo Pharma Limited
02 1CHANGZHOU KONY PHARMACEUTICAL CO., LTD. CN 213 105 Changzhou
03 1Charioteer
04 1Fareva
05 1RANBAXY LABORATORIES LIMITED
06 1Trifarma
01 3GANCICLOVIR
02 1GANCICLOVIR USP
03 1GANCICLOVIR USP (NON-STERILE API)
04 1GANCICLOVIR, USP
01 2China
02 2India
03 1Italy
04 1Luxembourg
01 4Active
02 2Inactive
01 3Complete
02 3Blank
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-07
Pay. Date : 2017-02-15
DMF Number : 31402
Submission : 2017-02-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-06-02
Pay. Date : 2015-08-07
DMF Number : 28973
Submission : 2015-04-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27133
Submission : 2013-05-02
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-30
Pay. Date : 2013-01-08
DMF Number : 15567
Submission : 2001-07-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16043
Submission : 2002-07-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23721
Submission : 2010-04-16
Status : Active
Type : II
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