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Approved Drug Products containing 21729 listed in the FDA Orange Book. Original Data : FDA Website

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01 OTSUKA (4)

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01 TABLET, ORALLY DISINTEGRATING;ORAL (4)

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01 DISCN (4)

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01 ABILIFY (4)

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01 Yes (4)

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TABLET, ORALLY DIS...
15MG **Federal Reg...
2006-06-07
21729
ABILIFY
DISCN
Yes
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TABLET, ORALLY DIS...
20MG **Federal Reg...
2006-06-07
21729
ABILIFY
DISCN
Yes
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TABLET, ORALLY DIS...
10MG **Federal Reg...
2006-06-07
21729
ABILIFY
DISCN
Yes
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TABLET, ORALLY DIS...
30MG **Federal Reg...
2006-06-07
21729
ABILIFY
DISCN
Yes
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Looking for FDA Orange Book APPLICATION 21729

Looking for FDA Orange Book APPLICATION 21729 4

19

Otsuka Chemical Co Ltd, based in Japan, is a pharmaceutical company.

One of their notable products is ARIPIPRAZOLE, with a corresponding application number 21729.

Regulatory Information DISCN

With a dosage strength 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route TABLET, ORALLY DISINTEGRATING; ORAL

Reference Listed Drug Yes

Approved since 2006-06-07

18

Otsuka Chemical Co Ltd, based in Japan, is a pharmaceutical company.

One of their notable products is ARIPIPRAZOLE, with a corresponding application number 21729.

Regulatory Information DISCN

With a dosage strength 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route TABLET, ORALLY DISINTEGRATING; ORAL

Reference Listed Drug Yes

Approved since 2006-06-07

17

Otsuka Chemical Co Ltd, based in Japan, is a pharmaceutical company.

One of their notable products is ARIPIPRAZOLE, with a corresponding application number 21729.

Regulatory Information DISCN

With a dosage strength 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route TABLET, ORALLY DISINTEGRATING; ORAL

Reference Listed Drug Yes

Approved since 2006-06-07

16

Otsuka Chemical Co Ltd, based in Japan, is a pharmaceutical company.

One of their notable products is ARIPIPRAZOLE, with a corresponding application number 21729.

Regulatory Information DISCN

With a dosage strength 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route TABLET, ORALLY DISINTEGRATING; ORAL

Reference Listed Drug Yes

Approved since 2006-06-07

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