An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 021762
Company: ORGANON LLC

Medication Guide

Other Important Information from FDA

Products on NDA 021762

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021762

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

Labels for NDA 021762

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

Top