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Approved Drug Products containing 20405 listed in the FDA Orange Book. Original Data : FDA Website

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01 CONCORDIA (6)

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01 TABLET;ORAL (6)

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01 DISCN (3)

02 RX (3)

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01 LANOXIN (6)

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01 No (2)

02 Yes (4)

URL Supplier Web Content
TABLET; ORAL
0.125MG
1997-09-30
20405
LANOXIN
RX
Yes
AB
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TABLET; ORAL
0.375MG
1997-09-30
20405
LANOXIN
DISCN
No
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TABLET; ORAL
0.1875MG
1997-09-30
20405
LANOXIN
DISCN
Yes
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TABLET; ORAL
0.0625MG
1997-09-30
20405
LANOXIN
RX
Yes
AB
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TABLET; ORAL
0.5MG
1997-09-30
20405
LANOXIN
DISCN
No
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TABLET; ORAL
0.25MG
1997-09-30
20405
LANOXIN
RX
Yes
AB
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Looking for FDA Orange Book APPLICATION 20405

Looking for FDA Orange Book APPLICATION 20405 6

19

Concordia International, based in United Kingdom, is a pharmaceutical company.

One of their notable products is DIGOXIN, with a corresponding application number 20405.

Regulatory Information RX

With a dosage strength 0.125MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 1997-09-30

Therapeutic Equivalence (TE) Code AB

18

Concordia International, based in United Kingdom, is a pharmaceutical company.

One of their notable products is DIGOXIN, with a corresponding application number 20405.

Regulatory Information DISCN

With a dosage strength 0.375MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 1997-09-30

17

Concordia International, based in United Kingdom, is a pharmaceutical company.

One of their notable products is DIGOXIN, with a corresponding application number 20405.

Regulatory Information DISCN

With a dosage strength 0.1875MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 1997-09-30

16

Concordia International, based in United Kingdom, is a pharmaceutical company.

One of their notable products is DIGOXIN, with a corresponding application number 20405.

Regulatory Information RX

With a dosage strength 0.0625MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 1997-09-30

Therapeutic Equivalence (TE) Code AB

15

Concordia International, based in United Kingdom, is a pharmaceutical company.

One of their notable products is DIGOXIN, with a corresponding application number 20405.

Regulatory Information DISCN

With a dosage strength 0.5MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 1997-09-30

14

Concordia International, based in United Kingdom, is a pharmaceutical company.

One of their notable products is DIGOXIN, with a corresponding application number 20405.

Regulatory Information RX

With a dosage strength 0.25MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 1997-09-30

Therapeutic Equivalence (TE) Code AB

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