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Approved Drug Products containing 21590 listed in the FDA Orange Book. Original Data : FDA Website

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01 JAZZ (6)

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01 TABLET, ORALLY DISINTEGRATING;ORAL (6)

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01 DISCN (6)

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01 FAZACLO ODT (6)

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01 No (1)

02 Yes (5)

URL Supplier Web Content
TABLET, ORALLY DIS...
12.5MG **Federal R...
2007-05-30
21590
FAZACLO ODT
DISCN
Yes
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TABLET, ORALLY DIS...
100MG **Federal Re...
2004-02-10
21590
FAZACLO ODT
DISCN
Yes
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TABLET, ORALLY DIS...
150MG **Federal Re...
2010-07-09
21590
FAZACLO ODT
DISCN
Yes
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TABLET, ORALLY DIS...
50MG **Federal Reg...
2005-06-03
21590
FAZACLO ODT
DISCN
No
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TABLET, ORALLY DIS...
25MG **Federal Reg...
2004-02-10
21590
FAZACLO ODT
DISCN
Yes
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TABLET, ORALLY DIS...
200MG **Federal Re...
2010-07-09
21590
FAZACLO ODT
DISCN
Yes
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Looking for FDA Orange Book APPLICATION 21590

Looking for FDA Orange Book APPLICATION 21590 6

19

Jazz Pharmaceuticals, based in Ireland, is a pharmaceutical company.

One of their notable products is CLOZAPINE, with a corresponding application number 21590.

Regulatory Information DISCN

With a dosage strength 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 2007-05-30

18

Jazz Pharmaceuticals, based in Ireland, is a pharmaceutical company.

One of their notable products is CLOZAPINE, with a corresponding application number 21590.

Regulatory Information DISCN

With a dosage strength 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 2004-02-10

17

Jazz Pharmaceuticals, based in Ireland, is a pharmaceutical company.

One of their notable products is CLOZAPINE, with a corresponding application number 21590.

Regulatory Information DISCN

With a dosage strength 150MG **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 2010-07-09

16

Jazz Pharmaceuticals, based in Ireland, is a pharmaceutical company.

One of their notable products is CLOZAPINE, with a corresponding application number 21590.

Regulatory Information DISCN

With a dosage strength 50MG **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 No

Approved since 2005-06-03

15

Jazz Pharmaceuticals, based in Ireland, is a pharmaceutical company.

One of their notable products is CLOZAPINE, with a corresponding application number 21590.

Regulatory Information DISCN

With a dosage strength 25MG **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 2004-02-10

14

Jazz Pharmaceuticals, based in Ireland, is a pharmaceutical company.

One of their notable products is CLOZAPINE, with a corresponding application number 21590.

Regulatory Information DISCN

With a dosage strength 200MG **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 2010-07-09

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