01 1CARTEOLOL HCL
02 1CDHP
03 1COMMERCIAL BULK PLANT OF SECOND TOKUSHIMA FACTORY IN TOKUSHIMA, JAPAN
04 1DIINDOLYLMETHANE DRUG SUBSTANCE
05 1FACILITIES AND OPERATING PROCEDURES AT THE SAGA FACTORY, JAPAN
06 1FORMULATION RESEARCH INSTITUTE IN TOKUSHIMA, JAPAN
07 1FTORAFUR (ALSO CALLED FUTRAFUL OR TEGAFUR)
08 1GTS-21
09 1IODIPAMIDE DRUG SUBSTANCE
10 1IOHEXOL DRUG SUBSTANCE, FOR ORAL PRODUCTS
11 1IPD-1151T DRUG SUBSTANCE
12 3MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN TOKUSHIMA, JAPAN.
13 1NADIFLOXACIN DRUG SUBSTANCE
14 1NO-1886 DRUG SUBSTANCE
15 1OPA-15406 DRUG SUBSTANCE
16 1P-METHOXYBENZYL (6R,7R)-3-CHLOROMETHYL-8-OXO-7-PHENYLACETAMIDO-5-THIA-1-AZABICYCLO [4.2.0]OCT-2-ENE-2-CARBOXYLATE GCLE CHEMICAL SUBSTANCE
17 1P-METHOXYBENZYL(6R,7R)-3-CHLOROMETHYL-8-OXO-7-PHENYLACETAMIDO-5-THIA-1-AZABICYCLO [4.2.0]OCT-2-ENE-2-CARBOXYLATE, GCLE
18 1PROCATEROL HYDROCHLORIDE HEMIHYDRATE
19 1PROCATEROL, AEROSOL FORMULATION PRODUCED IN TOKUSHIMA FACTORY
20 1REBAMIPIDE(OPC-12759) DRUG SUBSTANCE
21 1STERILE WATER FOR INJECTION USP, 2 ML VIAL
22 1TAC-101 DRUG SUBSTANCE
23 1TAS-103
24 1TAZOBACTAM
25 1TEGAFUR
26 1TIPIRACIL HYDROCHLORIDE (TPI)
27 1TRIFLURIDINE DRUG SUBSTANCE
28 1Trospium Chloride
29 1UFT CAPSULES (TEGAFUR AND URACIL)
01 4INTERPHARMA PRAHA AS
02 1OTSUKA AMERICA PHARMACEUTICAL INC
03 2OTSUKA CHEMICAL CO LTD
04 1OTSUKA CHEMICAL INDIA PRIVATE LTD
05 13OTSUKA PHARMACEUTICAL CO LTD
06 2TAIHO PHARMACEUTICAL CO INC
07 8TAIHO PHARMACEUTICAL CO LTD
01 4Czech Republic
02 27Japan
01 6Active
02 25Inactive
01 1Complete
02 30Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2671
Submission : 1976-05-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12554
Submission : 1997-06-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16998
Submission : 2003-12-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4235
Submission : 1981-08-05
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14645
Submission : 1999-12-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10576
Submission : 1993-11-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26641
Submission : 2013-01-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17336
Submission : 2004-04-12
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12418
Submission : 1997-03-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13285
Submission : 1998-10-15
Status : Inactive
Type : II
Otsuka Holdings is a supplier offers 2 products (APIs, Excipients or Intermediates).
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