Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021823
Company: WARNER CHILCOTT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACTONEL WITH CALCIUM (COPACKAGED) CALCIUM CARBONATE; RISEDRONATE SODIUM EQ 500MG BASE,N/A;N/A,35MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, TABLET;ORAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/12/2005 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021823lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021823ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021823orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/08/2015 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021823s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021823Orig1s011ltr.pdf
03/26/2015 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021823s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021823Orig1s010ltr.pdf
04/19/2013 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021823s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021823Orig1s009ltr.pdf
08/22/2011 SUPPL-8 REMS-Assessment Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021823s008ltr.pdf
01/25/2011 SUPPL-7 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021823s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021823s006,s007ltr.pdf
01/25/2011 SUPPL-6 REMS-Proposal Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021823s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021823s006,s007ltr.pdf
08/22/2006 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021823s004_LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021823s004_LTR.pdf
06/19/2006 SUPPL-3 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021823s003LTR.pdf
01/24/2006 SUPPL-2 Labeling 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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/08/2015 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021823s011lbl.pdf
03/26/2015 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021823s010lbl.pdf
04/19/2013 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021823s009lbl.pdf
01/25/2011 SUPPL-7 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021823s006s007lbl.pdf
01/25/2011 SUPPL-6 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021823s006s007lbl.pdf
08/22/2006 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021823s004_LBL.pdf
01/24/2006 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020835s019, 021823s002lbl.pdf
08/12/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021823lbl.pdf

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