Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021762
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FOSAMAX PLUS D ALENDRONATE SODIUM; CHOLECALCIFEROL EQ 70MG BASE;2,800 IU TABLET;ORAL Prescription None Yes No
FOSAMAX PLUS D ALENDRONATE SODIUM; CHOLECALCIFEROL EQ 70MG BASE;5,600 IU TABLET;ORAL Prescription None 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
04/07/2005 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021762lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021762ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021762s000_FosamaxTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/16/2019 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021762s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021762Orig1s022ltr.pdf
11/30/2015 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021762s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021762Orig1s021ltr.pdf
04/08/2015 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021762s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021762Orig1s020ltr.pdf
07/10/2015 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

11/07/2013 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021762s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021762Orig1s018ltr.pdf
04/19/2013 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021762s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021762Orig1s017ltr.pdf
07/01/2011 SUPPL-15 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021762s015ltr.pdf
01/25/2011 SUPPL-13 REMS-Proposal Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021762s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021762s013ltr.pdf
03/01/2010 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021762s005s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021762s005s009sS010ltr.pdf
03/01/2010 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021762s005s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021762s005s009sS010ltr.pdf
10/08/2008 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020560s052,021575s013,021762s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020560s052, 021575s013, 021762s006ltr.pdf
03/01/2010 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021762s005s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021762s005s009sS010ltr.pdf
04/26/2007 SUPPL-4 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021762s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021762s004ltr.pdf
12/28/2006 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020560s47s48,021575s10s11,021762s2s3lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020560s47s48,021575s10s11,021762s2s3ltr.pdf
12/28/2006 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020560s47s48,021575s10s11,021762s2s3lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020560s47s48,021575s10s11,021762s2s3ltr.pdf
11/02/2005 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021762s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021762s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/16/2019 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021762s022lbl.pdf
11/30/2015 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021762s021lbl.pdf
04/08/2015 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021762s020lbl.pdf
11/07/2013 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021762s018lbl.pdf
04/19/2013 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021762s017lbl.pdf
01/25/2011 SUPPL-13 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021762s013lbl.pdf
03/01/2010 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021762s005s009s010lbl.pdf
03/01/2010 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021762s005s009s010lbl.pdf
03/01/2010 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021762s005s009s010lbl.pdf
10/08/2008 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020560s052,021575s013,021762s006lbl.pdf
04/26/2007 SUPPL-4 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021762s004lbl.pdf
12/28/2006 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020560s47s48,021575s10s11,021762s2s3lbl.pdf
12/28/2006 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020560s47s48,021575s10s11,021762s2s3lbl.pdf
11/02/2005 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021762s001lbl.pdf
04/07/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021762lbl.pdf

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