Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022560
Company: APIL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATELVIA RISEDRONATE SODIUM 35MG TABLET, DELAYED RELEASE;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
10/08/2010 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022560s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022560s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022560Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022560Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/08/2015 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022560s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022560Orig1s007ltr.pdf
03/26/2015 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022560s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022560Orig1s006ltr.pdf
04/19/2013 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022560s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022560Orig1s005ltr.pdf
08/13/2012 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022560s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022560Orig1s004ltr.pdf
08/22/2011 SUPPL-3 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022560s003ltr.pdf
01/25/2011 SUPPL-2 REMS-Proposal Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022560s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022560s001,s002ltr.pdf
01/25/2011 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022560s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022560s001,s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/08/2015 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022560s007lbl.pdf
03/26/2015 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022560s006lbl.pdf
04/19/2013 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022560s005lbl.pdf
08/13/2012 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022560s004lbl.pdf
01/25/2011 SUPPL-2 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022560s001lbl.pdf
01/25/2011 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022560s001lbl.pdf
10/08/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022560s000lbl.pdf

ATELVIA

TABLET, DELAYED RELEASE;ORAL; 35MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATELVIA RISEDRONATE SODIUM 35MG TABLET, DELAYED RELEASE;ORAL Prescription Yes AB 022560 APIL
RISEDRONATE SODIUM RISEDRONATE SODIUM 35MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 203217 TEVA PHARMS USA

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