01 1Taro Pharmaceutical Industries
02 3Alembic Pharmaceuticals Limited
03 2CSPC Pharmaceutical Group
04 1Calyx Chemicals & Pharmaceuticals Limited
05 2HEC Pharm
06 1Hainan Poly Pharm
07 1ITF CHEMICAL LTDA
08 1Jubilant Generics
09 2Lupin Ltd
10 1Mahima Life Sciences
11 1PJ healthcare
12 1Quimica Sintetica
13 1Sandoz B2B
14 1Sterile India Pvt. Ltd
15 3TAPI Technology & API Services
16 3Wockhardt
17 1Zhejiang Guobang Pharmaceutical
01 1ANHYDROUS AZITHROMYCIN
02 1AZITHROMYCIN
03 1AZITHROMYCIN (LYOPHILIZED BULK STERILE)
04 1AZITHROMYCIN GRANULES FOR ORAL SUSPENSION
05 1AZITHROMYCIN HYDROGENCITRATE
06 1AZITHROMYCIN MONHYDRATE, NON-STERILE BULK DRUG SUBSTANCE
07 6AZITHROMYCIN MONOHYDRATE
08 1AZITHROMYCIN MONOHYDRATE (NON-STERILE BULK)
09 1AZITHROMYCIN MONOHYDRATE NON-STERILE BULK DRUG SUBSTANCE
10 4AZITHROMYCIN MONOHYDRATE USP
11 1AZITHROMYCIN MONOHYDRATE USP (PROCESS B)
12 1AZITHROMYCIN MONOHYDRATE USP (PROCESS-II)
13 1AZITHROMYCIN N
14 1AZITHROMYCIN TASTE MASKING GRANULES 7.5%
15 1AZITHROMYCIN USP
16 1AZITHROMYCIN USP (API)
17 1AZITHROMYCIN USP (DIHYDRATE)
18 1AZITHROMYCIN-FORM I
01 1Brazil
02 6China
03 13India
04 3Israel
05 1Spain
06 1Switzerland
07 1U.S.A
01 13Active
02 13Inactive
01 6Complete
02 20Blank
GDUFA
DMF Review : Complete
Rev. Date : 2015-06-29
Pay. Date : 2015-03-02
DMF Number : 28294
Submission : 2015-03-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-06
Pay. Date : 2013-09-26
DMF Number : 24754
Submission : 2011-02-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18719
Submission : 2005-08-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27713
Submission : 2013-09-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-16
Pay. Date : 2014-05-07
DMF Number : 22331
Submission : 2008-12-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-23
Pay. Date : 2012-12-17
DMF Number : 18868
Submission : 2005-10-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-23
Pay. Date : 2013-01-04
DMF Number : 25820
Submission : 2012-04-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-26
Pay. Date : 2012-11-13
DMF Number : 15985
Submission : 2002-05-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15261
Submission : 2001-01-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18073
Submission : 2005-02-11
Status : Active
Type : II
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