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Approved Drug Products of Otsuka Chemical Co Ltd listed in the FDA Orange Book. Original Data : FDA Website

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Otsuka Chemical Co Ltd
japan Flag
Country
Country
Japan
Address
Address
3-2-27, Ote-Dori, Chuo-Ku, Osaka, 540-0021
Telephone
Telephone
+81-6-6943-7701, +81 352 972 727
Linkedin
Linkedin
Twitter
Twitter

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TABLET; ORAL
10MG
2002-11-15
21436
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RX
Yes
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TABLET; ORAL
15MG
2002-11-15
21436
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TABLET; ORAL
20MG
2002-11-15
21436
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TABLET; ORAL
30MG
2002-11-15
21436
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TABLET; ORAL
5MG
2002-11-15
21436
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TABLET; ORAL
2MG
2002-11-15
21436
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SOLUTION; ORAL
1MG/ML **Federal R...
2004-12-10
21713
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DISCN
Yes
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TABLET, ORALLY DIS...
10MG **Federal Reg...
2006-06-07
21729
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DISCN
Yes
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TABLET, ORALLY DIS...
15MG **Federal Reg...
2006-06-07
21729
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DISCN
Yes
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TABLET, ORALLY DIS...
20MG **Federal Reg...
2006-06-07
21729
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Yes
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TABLET, ORALLY DIS...
30MG **Federal Reg...
2006-06-07
21729
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INJECTABLE; INTRAM...
9.75MG/1.3ML (7.5M...
2006-09-20
21866
ABILIFY
DISCN
No
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TABLET; ORAL
2MG
2017-11-13
207202
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RX
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TABLET; ORAL
5MG
2017-11-13
207202
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RX
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TABLET; ORAL
10MG
2017-11-13
207202
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TABLET; ORAL
15MG
2017-11-13
207202
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TABLET; ORAL
20MG
2017-11-13
207202
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TABLET; ORAL
30MG
2017-11-13
207202
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SUSPENSION, EXTEND...
720MG/2.4ML (300MG...
2023-04-27
217006
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RX
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SUSPENSION, EXTEND...
960MG/3.2ML (300MG...
2023-04-27
217006
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TABLET; ORAL
0.25MG
2015-07-10
205422
REXULTI
RX
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TABLET; ORAL
0.5MG
2015-07-10
205422
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TABLET; ORAL
1MG
2015-07-10
205422
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TABLET; ORAL
2MG
2015-07-10
205422
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TABLET; ORAL
3MG
2015-07-10
205422
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TABLET; ORAL
4MG
2015-07-10
205422
REXULTI
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TABLET; ORAL
100MG;35MG
2020-07-07
212576
INQOVI
RX
Yes
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TABLET; ORAL
50MG **Federal Reg...
1999-01-15
20863
PLETAL
DISCN
Yes
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TABLET; ORAL
100MG **Federal Re...
1999-01-15
20863
PLETAL
DISCN
Yes
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INJECTABLE; INTRAV...
50MG/VIAL
2006-05-02
21790
DACOGEN
DISCN
Yes
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FOR SOLUTION; ORAL
600MG/PACKET
1997-10-14
20292
FERRISELTZ
DISCN
No
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TABLET; ORAL
EQ 200MG BASE
1997-11-06
20695
RAXAR
DISCN
No
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TABLET; ORAL
EQ 400MG BASE
1998-05-14
20695
RAXAR
DISCN
No
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TABLET; ORAL
EQ 600MG BASE
1998-05-14
20695
RAXAR
DISCN
No
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TABLET; ORAL
15MG
2009-05-19
22275
SAMSCA
RX
Yes
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TABLET; ORAL
30MG
2009-05-19
22275
SAMSCA
RX
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TABLET; ORAL
60MG **Federal Reg...
2009-05-19
22275
SAMSCA
DISCN
Yes
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TABLET; ORAL
15MG
2018-04-23
204441
JYNARQUE
RX
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TABLET; ORAL
30MG
2018-04-23
204441
JYNARQUE
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TABLET; ORAL
45MG
2018-04-23
204441
JYNARQUE
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TABLET; ORAL
60MG
2018-04-23
204441
JYNARQUE
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TABLET; ORAL
90MG
2018-04-23
204441
JYNARQUE
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