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Approved Drug Products containing 21485 listed in the FDA Orange Book. Original Data : FDA Website

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01 ORION PHARMA (6)

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01 TABLET;ORAL (6)

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01 RX (6)

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01 STALEVO 100 (1)

02 STALEVO 125 (1)

03 STALEVO 150 (1)

04 STALEVO 200 (1)

05 STALEVO 50 (1)

06 STALEVO 75 (1)

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01 Yes (6)

URL Supplier Web Content
TABLET; ORAL
12.5MG;200MG;50MG
2003-06-11
21485
STALEVO 50
RX
Yes
AB
Fermion Orion Company Banner

RDD 2024

Not Confirmed

envelop Contact Supplier
URL Supplier Web Content
TABLET; ORAL
31.25MG;200MG;125M...
2008-08-29
21485
STALEVO 125
RX
Yes
AB
Fermion Orion Company Banner

RDD 2024

Not Confirmed

envelop Contact Supplier
URL Supplier Web Content
TABLET; ORAL
50MG;200MG;200MG
2007-08-02
21485
STALEVO 200
RX
Yes
AB
Fermion Orion Company Banner

RDD 2024

Not Confirmed

envelop Contact Supplier
URL Supplier Web Content
TABLET; ORAL
25MG;200MG;100MG
2003-06-11
21485
STALEVO 100
RX
Yes
AB
Fermion Orion Company Banner

RDD 2024

Not Confirmed

envelop Contact Supplier
URL Supplier Web Content
TABLET; ORAL
18.75MG;200MG;75MG
2008-08-29
21485
STALEVO 75
RX
Yes
AB
Fermion Orion Company Banner

RDD 2024

Not Confirmed

envelop Contact Supplier
URL Supplier Web Content
TABLET; ORAL
37.5MG;200MG;150MG
2003-06-11
21485
STALEVO 150
RX
Yes
AB
Fermion Orion Company Banner

RDD 2024

Not Confirmed

envelop Contact Supplier

Looking for FDA Orange Book APPLICATION 21485

Looking for FDA Orange Book APPLICATION 21485 6

19

Orion Corporation, based in Finland, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is CARBIDOPA; ENTACAPONE; LEVODOPA, with a corresponding application number 21485.

Regulatory Information RX

With a dosage strength 12.5MG;200MG;50MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 2003-06-11

Therapeutic Equivalence (TE) Code AB

18

Orion Corporation, based in Finland, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is CARBIDOPA; ENTACAPONE; LEVODOPA, with a corresponding application number 21485.

Regulatory Information RX

With a dosage strength 31.25MG;200MG;125MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 2008-08-29

Therapeutic Equivalence (TE) Code AB

17

Orion Corporation, based in Finland, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is CARBIDOPA; ENTACAPONE; LEVODOPA, with a corresponding application number 21485.

Regulatory Information RX

With a dosage strength 50MG;200MG;200MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 2007-08-02

Therapeutic Equivalence (TE) Code AB

16

Orion Corporation, based in Finland, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is CARBIDOPA; ENTACAPONE; LEVODOPA, with a corresponding application number 21485.

Regulatory Information RX

With a dosage strength 25MG;200MG;100MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 2003-06-11

Therapeutic Equivalence (TE) Code AB

15

Orion Corporation, based in Finland, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is CARBIDOPA; ENTACAPONE; LEVODOPA, with a corresponding application number 21485.

Regulatory Information RX

With a dosage strength 18.75MG;200MG;75MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 2008-08-29

Therapeutic Equivalence (TE) Code AB

14

Orion Corporation, based in Finland, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is CARBIDOPA; ENTACAPONE; LEVODOPA, with a corresponding application number 21485.

Regulatory Information RX

With a dosage strength 37.5MG;200MG;150MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 2003-06-11

Therapeutic Equivalence (TE) Code AB

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