Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020835
Company: APIL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACTONEL RISEDRONATE SODIUM 30MG TABLET;ORAL Prescription AB Yes No
ACTONEL RISEDRONATE SODIUM 5MG TABLET;ORAL Prescription AB Yes No
ACTONEL RISEDRONATE SODIUM 35MG TABLET;ORAL Prescription AB Yes Yes
ACTONEL RISEDRONATE SODIUM 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
ACTONEL RISEDRONATE SODIUM 150MG TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/27/1998 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Letter
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20835_Actonel.htm https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20835_Actonel.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/22/2015 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

04/08/2015 SUPPL-48 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020835s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020835Orig1s048ltr.pdf
03/26/2015 SUPPL-47 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020835s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020835Orig1s047ltr.pdf
12/02/2014 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

04/19/2013 SUPPL-45 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020835s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020835Orig1s045ltr.pdf
08/22/2011 SUPPL-44 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020835s044ltr.pdf
01/25/2011 SUPPL-43 REMS-Proposal Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020835s042s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020835s042,s043ltr.pdf
01/25/2011 SUPPL-42 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020835s042s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020835s042,s043ltr.pdf
12/31/2009 SUPPL-36 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020835s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020835s036ltr.pdf
07/23/2009 SUPPL-35 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020835s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020835s035ltr.pdf
04/22/2008 SUPPL-30 Efficacy-New Dosing Regimen Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020835s029, s030ltr.pdf
04/22/2008 SUPPL-29 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020835s029, s030ltr.pdf
07/24/2007 SUPPL-28 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020835s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020835s028ltr.pdf
04/16/2007 SUPPL-25 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020835s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020835s025ltr.pdf
08/11/2006 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020835s022s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020835s022, 020835s023LTR.pdf
08/11/2006 SUPPL-22 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020835s022s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020835s022, 020835s023LTR.pdf
09/12/2005 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020835s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020835s020ltr.pdf
01/24/2006 SUPPL-19 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020835s019, 021823s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020835s019_021823s002ltr.pdf
05/06/2005 SUPPL-18 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020835s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020835s018ltr.pdf
02/24/2004 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20835slr014_actionel_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20835slr014ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020835_S014_ACTONEL TABLETS.pdf
12/10/2002 SUPPL-12 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020835_S012_ACTONEL.pdf
11/05/2002 SUPPL-11 Manufacturing (CMC)-Packaging Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020835_S011_ACTONEL.pdf
09/26/2002 SUPPL-10 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020835_S010_ACTENOL.pdf
05/17/2002 SUPPL-9 Efficacy-New Dosing Regimen Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20835s008ltr.pdf
05/17/2002 SUPPL-8 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/020835s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20835s008ltr.pdf
12/21/2001 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

05/02/2001 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

04/14/2000 SUPPL-4 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20835s1s2s3s4lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20835s1-2-3-4ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20835S001_Actonel.cfm
04/14/2000 SUPPL-3 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20835s1s2s3s4lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20835s1-2-3-4ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20835S001_Actonel.cfm
04/14/2000 SUPPL-2 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20835s1s2s3s4lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20835s1-2-3-4ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20835S001_Actonel.cfm
04/14/2000 SUPPL-1 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20835s1s2s3s4lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20835s1-2-3-4ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20835S001_Actonel.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/08/2015 SUPPL-48 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020835s048lbl.pdf
03/26/2015 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020835s047lbl.pdf
04/19/2013 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020835s045lbl.pdf
01/25/2011 SUPPL-43 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020835s042s043lbl.pdf
01/25/2011 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020835s042s043lbl.pdf
12/31/2009 SUPPL-36 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020835s036lbl.pdf
07/23/2009 SUPPL-35 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020835s035lbl.pdf
07/24/2007 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020835s028lbl.pdf
04/16/2007 SUPPL-25 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020835s025lbl.pdf
08/11/2006 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020835s022s023lbl.pdf
08/11/2006 SUPPL-22 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020835s022s023lbl.pdf
01/24/2006 SUPPL-19 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020835s019, 021823s002lbl.pdf
09/12/2005 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020835s020lbl.pdf
05/06/2005 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020835s018lbl.pdf
02/24/2004 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20835slr014_actionel_lbl.pdf
05/17/2002 SUPPL-8 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/020835s008lbl.pdf
04/14/2000 SUPPL-4 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20835s1s2s3s4lbl.pdf
04/14/2000 SUPPL-3 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20835s1s2s3s4lbl.pdf
04/14/2000 SUPPL-2 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20835s1s2s3s4lbl.pdf
04/14/2000 SUPPL-1 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20835s1s2s3s4lbl.pdf

ACTONEL

TABLET;ORAL; 30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACTONEL RISEDRONATE SODIUM 30MG TABLET;ORAL Prescription Yes AB 020835 APIL
RISEDRONATE SODIUM RISEDRONATE SODIUM 30MG TABLET;ORAL Prescription No AB 200296 AUROBINDO PHARMA LTD
RISEDRONATE SODIUM RISEDRONATE SODIUM 30MG TABLET;ORAL Prescription No AB 203533 MACLEODS PHARMS LTD
RISEDRONATE SODIUM RISEDRONATE SODIUM 30MG TABLET;ORAL Prescription No AB 200477 MYLAN PHARMS INC
RISEDRONATE SODIUM RISEDRONATE SODIUM 30MG TABLET;ORAL Prescription No AB 090886 SUN PHARMA GLOBAL
RISEDRONATE SODIUM RISEDRONATE SODIUM 30MG TABLET;ORAL Prescription No AB 077132 TEVA PHARMS USA

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACTONEL RISEDRONATE SODIUM 5MG TABLET;ORAL Prescription Yes AB 020835 APIL
RISEDRONATE SODIUM RISEDRONATE SODIUM 5MG TABLET;ORAL Prescription No AB 200296 AUROBINDO PHARMA LTD
RISEDRONATE SODIUM RISEDRONATE SODIUM 5MG TABLET;ORAL Prescription No AB 203533 MACLEODS PHARMS LTD
RISEDRONATE SODIUM RISEDRONATE SODIUM 5MG TABLET;ORAL Prescription No AB 200477 MYLAN PHARMS INC
RISEDRONATE SODIUM RISEDRONATE SODIUM 5MG TABLET;ORAL Prescription No AB 090886 SUN PHARMA GLOBAL
RISEDRONATE SODIUM RISEDRONATE SODIUM 5MG TABLET;ORAL Prescription No AB 077132 TEVA PHARMS USA

TABLET;ORAL; 35MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACTONEL RISEDRONATE SODIUM 35MG TABLET;ORAL Prescription Yes AB 020835 APIL
RISEDRONATE SODIUM RISEDRONATE SODIUM 35MG TABLET;ORAL Prescription No AB 090877 APOTEX INC
RISEDRONATE SODIUM RISEDRONATE SODIUM 35MG TABLET;ORAL Prescription No AB 200296 AUROBINDO PHARMA LTD
RISEDRONATE SODIUM RISEDRONATE SODIUM 35MG TABLET;ORAL Prescription No AB 203533 MACLEODS PHARMS LTD
RISEDRONATE SODIUM RISEDRONATE SODIUM 35MG TABLET;ORAL Prescription No AB 200477 MYLAN PHARMS INC
RISEDRONATE SODIUM RISEDRONATE SODIUM 35MG TABLET;ORAL Prescription No AB 090886 SUN PHARMA GLOBAL
RISEDRONATE SODIUM RISEDRONATE SODIUM 35MG TABLET;ORAL Prescription No AB 077132 TEVA PHARMS USA

TABLET;ORAL; 150MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACTONEL RISEDRONATE SODIUM 150MG TABLET;ORAL Prescription Yes AB 020835 APIL
RISEDRONATE SODIUM RISEDRONATE SODIUM 150MG TABLET;ORAL Prescription No AB 090877 APOTEX INC
RISEDRONATE SODIUM RISEDRONATE SODIUM 150MG TABLET;ORAL Prescription No AB 206768 AUROBINDO PHARMA LTD
RISEDRONATE SODIUM RISEDRONATE SODIUM 150MG TABLET;ORAL Prescription No AB 200477 MYLAN PHARMS INC
RISEDRONATE SODIUM RISEDRONATE SODIUM 150MG TABLET;ORAL Prescription No AB 090886 SUN PHARMA GLOBAL
RISEDRONATE SODIUM RISEDRONATE SODIUM 150MG TABLET;ORAL Prescription No AB 079215 TEVA PHARMS USA

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