01 1Ajinomoto OmniChem N.V.
02 1AstraZeneca
03 2Aurore Life Sciences
04 1Charioteer
05 1Cipla
06 1Hetero Drugs
07 1Hubei Yitai Pharmaceutical Co. , Ltd.
08 1Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.
09 2Mallinckrodt Pharmaceuticals
10 2Olon S.p.A
11 1Piramal Pharma Solutions
12 1Qidong Dongyue Pharmaceutical Co., Ltd.
13 1Quimica Sintetica
14 1RANBAXY LABORATORIES LIMITED
15 1Recordati
16 1ST Pharma
17 1Signa S.A. de C.V.
18 4TAPI Technology & API Services
19 1UQUIFA
20 1Viatris
21 2YUNG ZIP CHEMICAL INDUSTRIAL
22 1Zhejiang Zhebei Pharmaceutical
23 3Blank
01 16ACYCLOVIR
02 1ACYCLOVIR (NON-STERILE, BULK FORM)
03 1ACYCLOVIR (PROCESS II)
04 1ACYCLOVIR ACTIVE SUBSTANCE
05 2ACYCLOVIR DRUG SUBSTANCE
06 6ACYCLOVIR USP
07 1ACYCLOVIR USP (API)
08 1ACYCLOVIR USP (MICRONIZED), CODED 2524
09 1ACYCLOVIR USP [SITE KHAZIPALLY]
10 1ACYCLOVIR USP, BULK
11 1ACYCLOVIR, USP
01 1Belgium
02 5China
03 5India
04 2Ireland
05 4Israel
06 3Italy
07 1Mexico
08 1South Korea
09 2Spain
10 2Taiwan
11 2U.S.A
12 1United Kingdom
13 3Blank
01 18Active
02 14Inactive
01 14Complete
02 18Blank
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-07
Pay. Date : 2013-02-21
DMF Number : 20203
Submission : 2007-01-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20445
Submission : 2007-04-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-03-03
Pay. Date : 2014-04-22
DMF Number : 10685
Submission : 1994-01-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-07
Pay. Date : 2014-01-29
DMF Number : 8584
Submission : 1990-05-25
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-29
Pay. Date : 2013-06-04
DMF Number : 10044
Submission : 1993-01-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-24
Pay. Date : 2013-04-04
DMF Number : 16144
Submission : 2002-09-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-09
Pay. Date : 2013-04-26
DMF Number : 11896
Submission : 1996-03-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-26
Pay. Date : 2012-11-19
DMF Number : 13277
Submission : 1998-10-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10830
Submission : 1994-03-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-20
Pay. Date : 2013-03-22
DMF Number : 19948
Submission : 2006-11-01
Status : Active
Type : II
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