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Athena Athena

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Approved Drug Products containing 20560 listed in the FDA Orange Book. Original Data : FDA Website

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01 ORGANON (5)

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01 TABLET;ORAL (5)

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01 DISCN (4)

02 RX (1)

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01 FOSAMAX (5)

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01 Yes (5)

URL Supplier Web Content
TABLET; ORAL
EQ 70MG BASE
2000-10-20
20560
FOSAMAX
RX
Yes
AB
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URL Supplier Web Content
TABLET; ORAL
EQ 5MG BASE **Fede...
1997-04-25
20560
FOSAMAX
DISCN
Yes
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TABLET; ORAL
EQ 10MG BASE **Fed...
1995-09-29
20560
FOSAMAX
DISCN
Yes
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TABLET; ORAL
EQ 35MG BASE **Fed...
2000-10-20
20560
FOSAMAX
DISCN
Yes
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TABLET; ORAL
EQ 40MG BASE **Fed...
1995-09-29
20560
FOSAMAX
DISCN
Yes
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Looking for FDA Orange Book APPLICATION 20560

Looking for FDA Orange Book APPLICATION 20560 5

19

Organon, based in U.S.A, is a pharmaceutical company.

One of their notable products is ALENDRONATE SODIUM, with a corresponding application number 20560.

Regulatory Information RX

With a dosage strength EQ 70MG BASE

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 2000-10-20

Therapeutic Equivalence (TE) Code AB

18

Organon, based in U.S.A, is a pharmaceutical company.

One of their notable products is ALENDRONATE SODIUM, with a corresponding application number 20560.

Regulatory Information DISCN

With a dosage strength EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 1997-04-25

17

Organon, based in U.S.A, is a pharmaceutical company.

One of their notable products is ALENDRONATE SODIUM, with a corresponding application number 20560.

Regulatory Information DISCN

With a dosage strength EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 1995-09-29

16

Organon, based in U.S.A, is a pharmaceutical company.

One of their notable products is ALENDRONATE SODIUM, with a corresponding application number 20560.

Regulatory Information DISCN

With a dosage strength EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 2000-10-20

15

Organon, based in U.S.A, is a pharmaceutical company.

One of their notable products is ALENDRONATE SODIUM, with a corresponding application number 20560.

Regulatory Information DISCN

With a dosage strength EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 1995-09-29

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