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Approved Drug Products containing 21829 listed in the FDA Orange Book. Original Data : FDA Website

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01 UCB INC (6)

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01 FILM, EXTENDED RELEASE;TRANSDERMAL (6)

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01 RX (6)

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01 NEUPRO (6)

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01 Yes (6)

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FILM, EXTENDED REL...
4MG/24HR
2007-05-09
21829
NEUPRO
RX
Yes
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FILM, EXTENDED REL...
3MG/24HR
2012-04-02
21829
NEUPRO
RX
Yes
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FILM, EXTENDED REL...
6MG/24HR
2007-05-09
21829
NEUPRO
RX
Yes
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FILM, EXTENDED REL...
2MG/24HR
2007-05-09
21829
NEUPRO
RX
Yes
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FILM, EXTENDED REL...
8MG/24HR
2012-04-02
21829
NEUPRO
RX
Yes
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FILM, EXTENDED REL...
1MG/24HR
2012-04-02
21829
NEUPRO
RX
Yes
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Looking for FDA Orange Book APPLICATION 21829

Looking for FDA Orange Book APPLICATION 21829 6

19

UCB Pharma S.A, based in Belgium, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is ROTIGOTINE, with a corresponding application number 21829.

Regulatory Information RX

With a dosage strength 4MG/24HR

Dosage Form Route FILM, EXTENDED RELEASE; TRANSDERMAL

Reference Listed Drug Yes

Approved since 2007-05-09

18

UCB Pharma S.A, based in Belgium, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is ROTIGOTINE, with a corresponding application number 21829.

Regulatory Information RX

With a dosage strength 3MG/24HR

Dosage Form Route FILM, EXTENDED RELEASE; TRANSDERMAL

Reference Listed Drug Yes

Approved since 2012-04-02

17

UCB Pharma S.A, based in Belgium, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is ROTIGOTINE, with a corresponding application number 21829.

Regulatory Information RX

With a dosage strength 6MG/24HR

Dosage Form Route FILM, EXTENDED RELEASE; TRANSDERMAL

Reference Listed Drug Yes

Approved since 2007-05-09

16

UCB Pharma S.A, based in Belgium, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is ROTIGOTINE, with a corresponding application number 21829.

Regulatory Information RX

With a dosage strength 2MG/24HR

Dosage Form Route FILM, EXTENDED RELEASE; TRANSDERMAL

Reference Listed Drug Yes

Approved since 2007-05-09

15

UCB Pharma S.A, based in Belgium, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is ROTIGOTINE, with a corresponding application number 21829.

Regulatory Information RX

With a dosage strength 8MG/24HR

Dosage Form Route FILM, EXTENDED RELEASE; TRANSDERMAL

Reference Listed Drug Yes

Approved since 2012-04-02

14

UCB Pharma S.A, based in Belgium, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is ROTIGOTINE, with a corresponding application number 21829.

Regulatory Information RX

With a dosage strength 1MG/24HR

Dosage Form Route FILM, EXTENDED RELEASE; TRANSDERMAL

Reference Listed Drug Yes

Approved since 2012-04-02

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