01 2AbbVie Inc
02 1Polfa Tarchomin
03 2ANGUS Chemical Company
04 5Abbott Laboratories
05 1Alembic Pharmaceuticals Limited
06 2Anuh Pharma LTD
07 1Calyx Chemicals & Pharmaceuticals Limited
08 3Eli Lilly
09 2Ercros
10 1Fermic
11 1Forest Laboratories
12 1HEC Pharm
13 1Kaneka Corporation
14 1Metabolic Solutions
15 3Ningxia Qiyuan Pharmaceutical
16 3Pfizer Inc
17 2SM BIOMED
18 2Sandoz B2B
19 1The Dow Chemical Company
20 1Unimax Group
21 2XIAN LIJUN PHARMACEUTICAL
22 1Zhejiang Guobang Pharmaceutical
23 5Blank
01 1AZAERYTHROMYCIN (U-GRADE)
02 1CONTROLLED RELEASE FORMULATION OF THE AMORPHOUS ERYTHROMYCIN ETHYLSUCCINATE
03 15ERYTHROMYCIN
04 1ERYTHROMYCIN (HIGH PURITY)
05 1ERYTHROMYCIN 500MG. C.R.TABLETS
06 1ERYTHROMYCIN A (E)-9-OXIME
07 1ERYTHROMYCIN B
08 3ERYTHROMYCIN BASE
09 1ERYTHROMYCIN BASE DIHYDRATE
10 1ERYTHROMYCIN BASE DIHYDRATE USP
11 1ERYTHROMYCIN BASE USP
12 1ERYTHROMYCIN BASE USP 23
13 1ERYTHROMYCIN BREATH TEST DOSE
14 1ERYTHROMYCIN ENTERIC-COATED TABLETS
15 1ERYTHROMYCIN PHOSPHATE
16 3ERYTHROMYCIN THIOCYANATE
17 2ERYTHROMYCIN USP
18 1ERYTHROMYCIN USP, NON-STERILE BULK FORM
19 1Erythromycin Oxime
20 1GALLIMYCIN (R)-10(ERYTHROMYCIN THIOCYANATE, ABBOTT)
21 1GALLIMYCIN-10(ERYTHROMYCIN,ABBOTT) & PRO-GEN (ARSANILIC ACID) (VET)
22 1INVEST DRUG STREPTOMYCIN,TYLOSIN, ERYTHROMYCIN & PENICILLIN BOLUS(VET)
23 1PCE
24 1STREPTOMYCIN-TYLOSIN-ERYTHROMYCIN-PENICILLIN COMBIN. ALONE & W/DES(VET
25 1ZOAMIX AND ERYTHROMYCIN THIOCYANATE (VET)
01 7China
02 5India
03 1Japan
04 2Malaysia
05 1Mexico
06 1Poland
07 2Spain
08 2Switzerland
09 18U.S.A
10 5Blank
01 15Active
02 29Inactive
01 8Complete
02 36Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13197
Submission : 1998-04-30
Status : Active
Type : II
Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13409
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-05-09
Pay. Date : 2013-09-25
DMF Number : 27155
Submission : 2015-11-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-15
Pay. Date : 2015-09-30
DMF Number : 22695
Submission : 2009-03-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-11-10
Pay. Date : 2016-09-27
DMF Number : 20137
Submission : 2006-12-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-24
Pay. Date : 2013-05-23
DMF Number : 13466
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-02
Pay. Date : 2014-09-30
DMF Number : 19444
Submission : 2006-03-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22332
Submission : 2008-12-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22390
Submission : 2008-12-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14630
Submission : 1999-12-15
Status : Active
Type : II
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