01 1Arch Pharmalabs
02 2Aurobindo Pharma Limited
03 1Cipla
04 1Esteve Quimica
05 1HEC Pharm
06 2Hetero Drugs
07 1MATRIX LABORATORIES XIAMEN LTD.
08 1Matrix Pharmaceutical Inc
09 1RANBAXY LABORATORIES LIMITED
10 1SIBRA PHARMACEUTICALS LTD
11 1ST Pharma
12 1Shanghai Desano Bio-Pharmaceutical
13 1Shanghai Shyndec Pharmaceutical
14 1Signa S.A. de C.V.
15 1Solara Active Pharma Sciences
16 3Viatris
17 1ZHEJIANG LANGHUA PHARMACEUTICAL CO., LTD.
01 2AZT (ZIDOVUDINE)
02 2ZIDOVUDINE
03 1ZIDOVUDINE (NON-STERILE, BULK FORM)
04 1ZIDOVUDINE (PROCESS I)
05 1ZIDOVUDINE (PROCESS II)
06 1ZIDOVUDINE DRUG SUBSTANCE
07 7ZIDOVUDINE USP
08 1ZIDOVUDINE USP (PROCESS II)
09 1ZIDOVUDINE USP (PROCESS III)
10 1ZIDOVUDINE USP (PROCESS-I)
11 1ZIDOVUDINE USP DRUG SUBSTANCE
12 1ZIDOVUDINE, NON-STERILE DRUG SUBSTANCE, BULK FORM
13 1ZIDOVUDINE, USP
01 5China
02 9India
03 1Mexico
04 1South Korea
05 1Spain
06 4U.S.A
01 10Active
02 11Inactive
01 5Complete
02 16Blank
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-21
Pay. Date : 2013-09-13
DMF Number : 18714
Submission : 2005-08-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17638
Submission : 2004-08-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16677
Submission : 2003-06-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23762
Submission : 2010-04-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-02
Pay. Date : 2013-01-04
DMF Number : 24608
Submission : 2011-02-03
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-06
Pay. Date : 2013-01-18
DMF Number : 18291
Submission : 2005-04-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-09
Pay. Date : 2012-12-14
DMF Number : 21277
Submission : 2008-01-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-08
Pay. Date : 2014-07-09
DMF Number : 27207
Submission : 2013-06-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25009
Submission : 2011-06-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17751
Submission : 2004-10-08
Status : Active
Type : II
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