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01 14-Biphenylacetic Acid
02 1Amrubicin
03 1Baclofen
04 3Bezafibrate
05 1Bicalutamide
06 1Bilastine
07 1Blonanserin
08 1Bovine Serum
09 1Cefpiramide
10 1Cinacalcet Hydrochloride
11 1Citalopram Hydrobromide
12 1Crotamiton
13 1Dipivefrin Hydrochloride
14 3Disopyramide
15 1Droxidopa
16 1Efinaconazole
17 1Enoxacin
18 1Fexofenadine Hydrochloride
19 1Fidaresstat
20 1Genaconazole
21 1Glipizide
22 1Hydralazine
23 2Hydralazine Hydrochloride
24 1Imatinib Mesylate
25 1Ipriflavone
26 1Ketosulfone
27 1Lacosamide
28 1Lanthanum Carbonate
29 1Levobunolol
30 2Lurasidone Hydrochloride
31 1Mequitazine
32 3Meropenem
33 1Metaqualone
34 1Milnacipran Hydrochloride
35 1Mirabegron
36 1Mirtazapine
37 2Mosapride Citrate
38 1Netoglitazone
39 1Olmesartan Medoxomil
40 2Olopatadine Hydrochloride
41 1Orbifloxacin
42 1Oteracil Potassium
43 1Oxaprozin
44 1Paroxetine Hydrochloride
45 1Phenethicillin Potassium
46 1Phenothrin
47 1Prazosin Hydrochloride
48 1Pregabalin
49 1Probucol
50 1Propylthiouracil
51 1Quetiapine Hemifumarate
52 1Ranirestat
53 1Rimacalib
54 1Rivaroxaban
55 1Sb 210232
56 1Sm-216601
57 1Smp 797
58 1Sodium Hyaluronate
59 1Sodium Valproate
60 1Sofpironium Bromide
61 1Sparfloxacin
62 1Telmisartan
63 1Terazosin HCl
64 1Thiazole
65 1Timolol Maleate
66 1Trientine Hydrochloride
67 2Tulobuterol
68 3Valsartan
69 1Vibegron
70 1Zonisamide
71 15Blank
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01 5Active
02 43Inactive
03 50Blank
01 2Valid
02 96Blank
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01 1217MF10074
02 1217MF10075
03 1217MF10077
04 1217MF10085
05 1217MF10086
06 1217MF10097
07 1217MF10099
08 1218MF10270
09 1218MF10740
10 1218MF10844
11 1219MF10226
12 1219MF10229
13 1219MF10230
14 1219MF10233
15 1219MF10375
16 1220MF10189
17 1222MF10051
18 1222MF10198
19 1222MF10199
20 1222MF10219
21 1222MF10231
22 1222MF10280
23 1223MF10088
24 1223MF10089
25 1223MF10164
26 1224MF10163
27 1224MF10238
28 1225MF10106
29 1225MF10202
30 1226MF10133
31 1227MF10015
32 1227MF10128
33 1227MF10130
34 1227MF10289
35 1227MF10290
36 1227MF10296
37 1228MF10108
38 1229MF10107
39 1229MF10123
40 1230MF10072
41 1301MF10027
42 1304MF10101
43 1306MF10075
44 1306MF10158
45 54Blank
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01 98Blank
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01 120110414-96-E-97-30
02 120200318-209-J-444
03 120240216-209-J-1612
04 121-2-ND
05 1247-12-ND
06 12474-1-ND
07 12487-1-ND
08 1Su132-9-ND
09 1Su216-24-ND
10 89Blank
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01 168259-1302
02 168259-1304
03 168259-1307
04 168259-1313
05 168259-1314
06 168259-1315
07 168259-1316
08 168259-1317
09 168259-1318
10 89Blank
01 98Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-09-20
Pay. Date : 2023-09-15
DMF Number : 2421
Submission : 1975-03-14
Status : Active
Type : II
Certificate Number : CEP 2018-170 - Rev 03
Issue Date : 2024-10-22
Type : Chemical
Substance Number : 829
Status : Valid
Registration Number : 219MF10233
Registrant's Address : 2-27-1 Shinkawa, Chuo-ku, Tokyo
Initial Date of Registration : 2007-07-06
Latest Date of Registration :
NDC Package Code : 68259-1313
Start Marketing Date : 2014-02-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4687
Submission : 1982-10-14
Status : Active
Type : II
Registration Number : 226MF10133
Registrant's Address : 2-27-1 Shinkawa, Chuo-ku, Tokyo
Initial Date of Registration : 2014-07-02
Latest Date of Registration :
NDC Package Code : 68259-1304
Start Marketing Date : 2009-06-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19311
Submission : 2006-03-31
Status : Inactive
Type : II
Registration Number : 222MF10219
Registrant's Address : 2-7-1 Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2010-08-10
Latest Date of Registration :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15300
Submission : 2001-02-22
Status : Inactive
Type : II
Registration Number : 229MF10107
Registrant's Address : 2-27-1 Shinkawa, Chuo-ku, Tokyo
Initial Date of Registration : 2017-06-21
Latest Date of Registration :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13908
Submission : 1998-12-22
Status : Inactive
Type : II
Registration Number : 219MF10375
Registrant's Address : 2-7-1 Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2007-12-19
Latest Date of Registration :
Registrant Name : Jeil Pharmaceutical Co., Ltd.
Registration Date : 2003-07-22
Registration Number : 21-2-ND
Manufacturer Name : Sumitomo Chemicals Co., Ltd. Gifu Plant, Oita Works
Manufacturer Address : 3750, Aza Juhachicho, Maki, Anpachicho, Anpachigun, Gifu Prefecture, 503-0125, Japan (27-1, Shinkawa 2-chome, Chuo-ku, Tokyo 104-8260, Japan)
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13888
Submission : 1998-12-07
Status : Inactive
Type : II
Registration Number : 222MF10199
Registrant's Address : 2-27-1 Shinkawa, Chuo-ku, Tokyo
Initial Date of Registration : 2010-07-14
Latest Date of Registration :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5631
Submission : 1984-11-30
Status : Inactive
Type : II
Registration Number : 225MF10106
Registrant's Address : 2-7-1 Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2013-05-20
Latest Date of Registration :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registration Number : 220MF10189
Registrant's Address : 2-7-1 Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2008-08-18
Latest Date of Registration :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registration Number : 222MF10051
Registrant's Address : 2-27-1 Shinkawa, Chuo-ku, Tokyo
Initial Date of Registration : 2010-02-12
Latest Date of Registration :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registration Number : 223MF10164
Registrant's Address : 2-7-1 Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2011-11-28
Latest Date of Registration :