01 1Aurobindo Pharma Limited
02 1Charioteer
03 1Chongqing Shenghuaxi Pharma. Co., Ltd
04 1Cipla
05 1Hetero Drugs
06 1Macleods Pharmaceuticals Limited
07 1Olon S.p.A
08 1Shanghai Pharma Group
09 1Signa S.A. de C.V.
10 1Teva API
11 1Zhejiang Hisun Pharmaceutical
01 6FAMCICLOVIR
02 1FAMCICLOVIR (NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT)
03 3FAMCICLOVIR USP
04 1FAMCYCLOVIR
01 4China
02 4India
03 1Israel
04 1Italy
05 1Mexico
01 9Active
02 2Inactive
01 2Complete
02 9Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22204
Submission : 2008-11-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34098
Submission : 2019-09-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19692
Submission : 2006-08-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19181
Submission : 2006-03-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23822
Submission : 2010-05-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22391
Submission : 2009-01-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-12-01
Pay. Date : 2020-08-21
DMF Number : 35050
Submission : 2020-08-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22713
Submission : 2009-04-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-23
Pay. Date : 2012-11-08
DMF Number : 17908
Submission : 2004-12-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18690
Submission : 2005-08-18
Status : Inactive
Type : II
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