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Approved Drug Products containing 21444 listed in the FDA Orange Book. Original Data : FDA Website

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01 JANSSEN PHARMS (5)

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01 TABLET, ORALLY DISINTEGRATING;ORAL (5)

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01 DISCN (5)

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01 RISPERDAL (5)

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01 Yes (5)

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TABLET, ORALLY DIS...
0.5MG **Federal Re...
2003-04-02
21444
RISPERDAL
DISCN
Yes
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TABLET, ORALLY DIS...
3MG **Federal Regi...
2004-12-23
21444
RISPERDAL
DISCN
Yes
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TABLET, ORALLY DIS...
1MG **Federal Regi...
2003-04-02
21444
RISPERDAL
DISCN
Yes
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TABLET, ORALLY DIS...
4MG **Federal Regi...
2004-12-23
21444
RISPERDAL
DISCN
Yes
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TABLET, ORALLY DIS...
2MG **Federal Regi...
2003-04-02
21444
RISPERDAL
DISCN
Yes
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Looking for FDA Orange Book APPLICATION 21444

Looking for FDA Orange Book APPLICATION 21444 5

19

Johnson & Johnson Innovative Medicine, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is RISPERIDONE, with a corresponding application number 21444.

Regulatory Information DISCN

With a dosage strength 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 2003-04-02

18

Johnson & Johnson Innovative Medicine, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is RISPERIDONE, with a corresponding application number 21444.

Regulatory Information DISCN

With a dosage strength 3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 2004-12-23

17

Johnson & Johnson Innovative Medicine, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is RISPERIDONE, with a corresponding application number 21444.

Regulatory Information DISCN

With a dosage strength 1MG **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 2003-04-02

16

Johnson & Johnson Innovative Medicine, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is RISPERIDONE, with a corresponding application number 21444.

Regulatory Information DISCN

With a dosage strength 4MG **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 2004-12-23

15

Johnson & Johnson Innovative Medicine, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is RISPERIDONE, with a corresponding application number 21444.

Regulatory Information DISCN

With a dosage strength 2MG **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 2003-04-02

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