01 3Actylis
02 1Ajinomoto Company
03 1Archimica
04 1Ash Stevens
05 1Biovectra Inc
06 1DALIAN ZHEN AO BIO TECH CO LTD
07 1Emcure Pharmaceuticals
08 1F. Hoffmann-La Roche
09 2Kyowa Hakko Bio
10 1Kyowa Pharma Chemical Co Ltd
11 1Reliable Biopharmaceutical Corporation
12 1Roche Diagnostics GmbH
13 2SIGMA TAU
14 1Wockhardt
15 1Zhejiang Hisun Pharmaceutical
16 1Blank
01 18-CHLOROADENOSINE
02 1ADENINE AND ADENINE HCL (SYNTHETIC & FROM RNA OR ADENOSINE)
03 6ADENOSINE
04 1ADENOSINE 5' -MONOPHOSPHATE FREE ACID
05 1ADENOSINE 5' TRIPHOSPHATE (ATP) DISODIUM SALT
06 1ADENOSINE DEAMINASE THERAPEUTIC GRADE
07 1ADENOSINE SUBLINGUAL TABLETS, 25 MG.
08 1ADENOSINE TRIPHOSPHATE DISODIUM
09 3ADENOSINE USP
10 1ADENOSINE, SIGMA GRADE
11 1ENZYME ADENOSINE DEAMINASE
12 1GP531T DRUG SUBSTANCE
13 1N6-(2-ISOPENTENYL)-ADENOSINE
01 1Canada
02 2China
03 1Germany
04 2India
05 1Italy
06 4Japan
07 1Switzerland
08 7U.S.A
09 1Blank
01 6Active
02 14Inactive
01 5Complete
02 15Blank
GDUFA
DMF Review : Complete
Rev. Date : 2013-06-08
Pay. Date : 2013-05-30
DMF Number : 7728
Submission : 1988-10-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3412
Submission : 1978-12-20
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-21
Pay. Date : 2013-09-17
DMF Number : 22232
Submission : 2008-11-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27732
Submission : 2014-02-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-06-18
Pay. Date : 2019-05-15
DMF Number : 33871
Submission : 2019-05-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8225
Submission : 1989-09-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4842
Submission : 1983-03-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4208
Submission : 1981-07-08
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-01
Pay. Date : 2015-11-23
DMF Number : 20071
Submission : 2007-05-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-08
Pay. Date : 2012-12-18
DMF Number : 17306
Submission : 2004-04-12
Status : Active
Type : II
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