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Approved Drug Products containing 205422 listed in the FDA Orange Book. Original Data : FDA Website

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01 OTSUKA (6)

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01 TABLET;ORAL (6)

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01 RX (6)

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01 REXULTI (6)

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01 Yes (6)

URL Supplier Web Content
TABLET; ORAL
1MG
2015-07-10
205422
REXULTI
RX
Yes
AB
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TABLET; ORAL
0.25MG
2015-07-10
205422
REXULTI
RX
Yes
AB
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TABLET; ORAL
4MG
2015-07-10
205422
REXULTI
RX
Yes
AB
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TABLET; ORAL
2MG
2015-07-10
205422
REXULTI
RX
Yes
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TABLET; ORAL
0.5MG
2015-07-10
205422
REXULTI
RX
Yes
AB
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TABLET; ORAL
3MG
2015-07-10
205422
REXULTI
RX
Yes
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Looking for FDA Orange Book APPLICATION 205422

Looking for FDA Orange Book APPLICATION 205422 6

19

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

One of their notable products is BREXPIPRAZOLE, with a corresponding application number 205422.

Regulatory Information RX

With a dosage strength 1MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 2015-07-10

Therapeutic Equivalence (TE) Code AB

18

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

One of their notable products is BREXPIPRAZOLE, with a corresponding application number 205422.

Regulatory Information RX

With a dosage strength 0.25MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 2015-07-10

Therapeutic Equivalence (TE) Code AB

17

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

One of their notable products is BREXPIPRAZOLE, with a corresponding application number 205422.

Regulatory Information RX

With a dosage strength 4MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 2015-07-10

Therapeutic Equivalence (TE) Code AB

16

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

One of their notable products is BREXPIPRAZOLE, with a corresponding application number 205422.

Regulatory Information RX

With a dosage strength 2MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 2015-07-10

Therapeutic Equivalence (TE) Code AB

15

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

One of their notable products is BREXPIPRAZOLE, with a corresponding application number 205422.

Regulatory Information RX

With a dosage strength 0.5MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 2015-07-10

Therapeutic Equivalence (TE) Code AB

14

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

One of their notable products is BREXPIPRAZOLE, with a corresponding application number 205422.

Regulatory Information RX

With a dosage strength 3MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 2015-07-10

Therapeutic Equivalence (TE) Code AB

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