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Approved Drug Products containing Risedronate Sodium Hydrate listed in the FDA Orange Book. Original Data : FDA Website

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01 APIL (6)

02 APOTEX (3)

03 AUROBINDO PHARMA (1)

04 AUROBINDO PHARMA LTD (3)

05 HANGZHOU BINJIANG (1)

06 IMPAX LABS INC (1)

07 MACLEODS PHARMS LTD (3)

08 MYLAN (5)

09 ORBION PHARMS (2)

10 SUN PHARM (6)

11 TEVA PHARMS USA (5)

12 WARNER CHILCOTT (1)

13 ZYDUS PHARMS (1)

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01 TABLET, DELAYED RELEASE;ORAL (5)

02 TABLET;ORAL (33)

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01 DISCN (12)

02 RX (26)

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01 ACTONEL (5)

02 ACTONEL WITH CALCIUM (COPACKAGED) (1)

03 ATELVIA (1)

04 RISEDRONATE SODIUM (31)

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01 No (31)

02 Yes (7)

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Digital Content Digital Content
URL Supplier Web Content
TABLET;ORAL
30MG
1998-03-27
20835
ACTONEL
DISCN
Yes
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TABLET;ORAL
5MG
2000-04-14
20835
ACTONEL
DISCN
Yes
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TABLET;ORAL
35MG
2002-05-25
20835
ACTONEL
RX
Yes
AB
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TABLET;ORAL
75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
2007-04-16
20835
ACTONEL
DISCN
Yes
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TABLET;ORAL
150MG
2008-04-22
20835
ACTONEL
RX
Yes
AB
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TABLET, DELAYED RELEASE;ORAL
35MG
2010-10-08
22560
ATELVIA
RX
Yes
AB
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TABLET;ORAL
5MG
2007-10-05
77132
RISEDRONATE SODIUM
RX
No
AB
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TABLET;ORAL
30MG
2007-10-05
77132
RISEDRONATE SODIUM
RX
No
AB
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TABLET;ORAL
35MG
2007-10-05
77132
RISEDRONATE SODIUM
RX
No
AB
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TABLET;ORAL
EQ 500MG BASE;35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
2005-08-12
21823
ACTONEL WITH CALCIUM (...
DISCN
Yes
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