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01 1BALSALAZIDE DISODIUM DIHYDRATE
02 1BENZOYL PEROXIDE, HYDROUS
03 1BETHANECHOL CHLORIDE
04 1CARBADOX
05 1CARBAMAZEPINE
06 1CHLORTHALIDONE
07 1CIMETIDINE
08 1CIMETIDINE HYDROCHLORIDE
09 1CLOTRIMAZOLE
10 1DESIPRAMINE HYDROCHLORIDE USP
11 1DICLOFENAC POTASSIUM
12 1DICLOFENAC SODIUM
13 1DISULFIRAM
14 1DOXYLAMINE SUCCINATE
15 1GUANETHIDINE SULFATE, USP
16 1IMIPRAMINE HCL USP
17 1IMIPRAMINE PAMOATE
18 1MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.
19 1MESALAMINE
20 1MESALAMINE HIGH DENSITY
21 1METAXALONE
22 1METHYLDOPA
23 1METRONIDAZOLE USP
24 1MICONAZOLE BASE
25 1MICONAZOLE NITRATE
26 1N-METHYL-1-METHYLTHIO-2-NITRO ETHENAMINE, TREVIGLIO, ITALY
27 1NAPROXEN SODIUM USP
28 1NAPROXEN USP
29 1OLSALAZINE SODIUM
30 1OXAPROZIN
31 1OXCARBAZEPINE
32 1RANITIDINE HYDROCHLORIDE
33 1SECNIDAZOLE
34 1SULFASALAZINE
35 1TINIDAZOLE USP XXI
36 1TIZANIDINE HYDROCHLORIDE
37 1TRIAMTERENE, USP
38 1TRIMETHOBENZAMIDE HCI
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01 17CORDEN PHARMA BERGAMO SPA
02 19FARCHEMIA SRL
03 1PHIBRO ANIMAL HEALTH CORP
04 1RISING PHARMA HOLDINGS INC
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01 38Italy
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01 6Active
02 32Inactive
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01 3Complete
02 35Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17500
Submission : 2004-06-25
Status : Inactive
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2013-06-24
Pay. Date : 2013-06-18
DMF Number : 14834
Submission : 2000-04-12
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15213
Submission : 2000-12-20
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5884
Submission : 1985-06-07
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9967
Submission : 1992-11-19
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 3445
Submission : 1977-11-01
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5497
Submission : 1984-07-30
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11583
Submission : 1995-07-11
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10713
Submission : 1994-02-04
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5367
Submission : 1984-04-20
Status : Inactive
Type : II

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