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01 4APOTEX

02 3AUROBINDO PHARMA

03 9CHARTWELL RX

04 5CIPLA

05 4HANGZHOU BINJIANG

06 1HIKMA

07 5IMPAX LABS INC

08 4IPCA LABS LTD

09 4JUBILANT CADISTA

10 1MERCK

11 2MYLAN

12 1NOVITIUM PHARMA

13 5ORGANON

14 2ORGANON LLC

15 1RADIUS

16 4RISING

17 4SUN PHARM

18 2TEVA PHARMS

19 3WATSON LABS

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PharmaCompass

01

euroPLX 86 Munich
Not Confirmed
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euroPLX 86 Munich
Not Confirmed

ALENDRONATE SODIUM

Brand Name : ALENDRONATE SODIUM

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 5MG BASE

Approval Date : 2008-02-06

Application Number : 75710

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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02

euroPLX 86 Munich
Not Confirmed
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euroPLX 86 Munich
Not Confirmed

ALENDRONATE SODIUM

Brand Name : ALENDRONATE SODIUM

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 10MG BASE

Approval Date : 2008-02-06

Application Number : 75710

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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03

euroPLX 86 Munich
Not Confirmed
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euroPLX 86 Munich
Not Confirmed

ALENDRONATE SODIUM

Brand Name : FOSAMAX

Dosage Form : SOLUTION;ORAL

Dosage Strength : EQ 70MG BASE/75ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2003-09-17

Application Number : 21575

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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04

euroPLX 86 Munich
Not Confirmed
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euroPLX 86 Munich
Not Confirmed

ALENDRONATE SODIUM

Brand Name : FOSAMAX

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1995-09-29

Application Number : 20560

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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05

euroPLX 86 Munich
Not Confirmed
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euroPLX 86 Munich
Not Confirmed

ALENDRONATE SODIUM

Brand Name : FOSAMAX

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1995-09-29

Application Number : 20560

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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06

euroPLX 86 Munich
Not Confirmed
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euroPLX 86 Munich
Not Confirmed

ALENDRONATE SODIUM

Brand Name : FOSAMAX

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1997-04-25

Application Number : 20560

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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07

euroPLX 86 Munich
Not Confirmed
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euroPLX 86 Munich
Not Confirmed

ALENDRONATE SODIUM

Brand Name : FOSAMAX

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2000-10-20

Application Number : 20560

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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08

euroPLX 86 Munich
Not Confirmed
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euroPLX 86 Munich
Not Confirmed

ALENDRONATE SODIUM

Brand Name : FOSAMAX

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 70MG BASE

Approval Date : 2000-10-20

Application Number : 20560

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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09

euroPLX 86 Munich
Not Confirmed
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euroPLX 86 Munich
Not Confirmed

ALENDRONATE SODIUM; CHOLECALCIFEROL

Brand Name : FOSAMAX PLUS D

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 70MG BASE;2,800 IU

Approval Date : 2005-04-07

Application Number : 21762

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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10

euroPLX 86 Munich
Not Confirmed
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euroPLX 86 Munich
Not Confirmed

ALENDRONATE SODIUM; CHOLECALCIFEROL

Brand Name : FOSAMAX PLUS D

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 70MG BASE;5,600 IU

Approval Date : 2007-04-26

Application Number : 21762

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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