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Approved Drug Products containing 78894 listed in the FDA Orange Book. Original Data : FDA Website

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01 ALEMBIC (5)

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01 TABLET;ORAL (5)

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01 DISCN (5)

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01 PRAMIPEXOLE DIHYDROCHLORIDE (5)

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01 No (5)

URL Supplier Web Content
TABLET; ORAL
0.5MG
2010-10-08
78894
PRAMIPEXOLE DIHYDR...
DISCN
No
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URL Supplier Web Content
TABLET; ORAL
0.125MG
2010-10-08
78894
PRAMIPEXOLE DIHYDR...
DISCN
No
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URL Supplier Web Content
TABLET; ORAL
1MG
2010-10-08
78894
PRAMIPEXOLE DIHYDR...
DISCN
No
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URL Supplier Web Content
TABLET; ORAL
0.25MG
2010-10-08
78894
PRAMIPEXOLE DIHYDR...
DISCN
No
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URL Supplier Web Content
TABLET; ORAL
1.5MG
2010-10-08
78894
PRAMIPEXOLE DIHYDR...
DISCN
No
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Looking for FDA Orange Book APPLICATION 78894

Looking for FDA Orange Book APPLICATION 78894 5

19

Alembic Pharmaceuticals Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is PRAMIPEXOLE DIHYDROCHLORIDE, with a corresponding application number 78894.

Regulatory Information DISCN

With a dosage strength 0.5MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2010-10-08

18

Alembic Pharmaceuticals Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is PRAMIPEXOLE DIHYDROCHLORIDE, with a corresponding application number 78894.

Regulatory Information DISCN

With a dosage strength 0.125MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2010-10-08

17

Alembic Pharmaceuticals Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is PRAMIPEXOLE DIHYDROCHLORIDE, with a corresponding application number 78894.

Regulatory Information DISCN

With a dosage strength 1MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2010-10-08

16

Alembic Pharmaceuticals Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is PRAMIPEXOLE DIHYDROCHLORIDE, with a corresponding application number 78894.

Regulatory Information DISCN

With a dosage strength 0.25MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2010-10-08

15

Alembic Pharmaceuticals Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is PRAMIPEXOLE DIHYDROCHLORIDE, with a corresponding application number 78894.

Regulatory Information DISCN

With a dosage strength 1.5MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2010-10-08

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