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01 6APIL

02 3APOTEX

03 1AUROBINDO PHARMA

04 3AUROBINDO PHARMA LTD

05 1HANGZHOU BINJIANG

06 1IMPAX LABS INC

07 3MACLEODS PHARMS LTD

08 5NORVIUM BIOSCIENCE

09 2ORBION PHARMS

10 6SUN PHARM

11 5TEVA PHARMS USA

12 1WARNER CHILCOTT

13 1ZYDUS PHARMS

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PharmaCompass

01

APIL

Country
Antibody Engineering
Not Confirmed
arrow

APIL

Country
arrow
Antibody Engineering
Not Confirmed

RISEDRONATE SODIUM

Brand Name : ACTONEL

Dosage Form : TABLET;ORAL

Dosage Strength : 30MG

Approval Date : 1998-03-27

Application Number : 20835

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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02

APIL

Country
Antibody Engineering
Not Confirmed
arrow

APIL

Country
arrow
Antibody Engineering
Not Confirmed

RISEDRONATE SODIUM

Brand Name : ACTONEL

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Approval Date : 2000-04-14

Application Number : 20835

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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03

APIL

Country
Antibody Engineering
Not Confirmed
arrow

APIL

Country
arrow
Antibody Engineering
Not Confirmed

RISEDRONATE SODIUM

Brand Name : ACTONEL

Dosage Form : TABLET;ORAL

Dosage Strength : 35MG

Approval Date : 2002-05-25

Application Number : 20835

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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04

APIL

Country
Antibody Engineering
Not Confirmed
arrow

APIL

Country
arrow
Antibody Engineering
Not Confirmed

RISEDRONATE SODIUM

Brand Name : ACTONEL

Dosage Form : TABLET;ORAL

Dosage Strength : 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2007-04-16

Application Number : 20835

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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05

APIL

Country
Antibody Engineering
Not Confirmed
arrow

APIL

Country
arrow
Antibody Engineering
Not Confirmed

RISEDRONATE SODIUM

Brand Name : ACTONEL

Dosage Form : TABLET;ORAL

Dosage Strength : 150MG

Approval Date : 2008-04-22

Application Number : 20835

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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06

APIL

Country
Antibody Engineering
Not Confirmed
arrow

APIL

Country
arrow
Antibody Engineering
Not Confirmed

RISEDRONATE SODIUM

Brand Name : ATELVIA

Dosage Form : TABLET, DELAYED RELEASE;ORAL

Dosage Strength : 35MG

Approval Date : 2010-10-08

Application Number : 22560

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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07

Antibody Engineering
Not Confirmed
arrow
arrow
Antibody Engineering
Not Confirmed

RISEDRONATE SODIUM

Brand Name : RISEDRONATE SODIUM

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Approval Date : 2007-10-05

Application Number : 77132

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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08

Antibody Engineering
Not Confirmed
arrow
arrow
Antibody Engineering
Not Confirmed

RISEDRONATE SODIUM

Brand Name : RISEDRONATE SODIUM

Dosage Form : TABLET;ORAL

Dosage Strength : 30MG

Approval Date : 2007-10-05

Application Number : 77132

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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09

Antibody Engineering
Not Confirmed
arrow
arrow
Antibody Engineering
Not Confirmed

RISEDRONATE SODIUM

Brand Name : RISEDRONATE SODIUM

Dosage Form : TABLET;ORAL

Dosage Strength : 35MG

Approval Date : 2007-10-05

Application Number : 77132

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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10

Antibody Engineering
Not Confirmed
arrow
arrow
Antibody Engineering
Not Confirmed

CALCIUM CARBONATE; RISEDRONATE SODIUM

Brand Name : ACTONEL WITH CALCIUM (COPACKAGED)

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 500MG BASE;35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2005-08-12

Application Number : 21823

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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