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): 021823
Company: WARNER CHILCOTT

Medication Guide

Other Important Information from FDA

Products on NDA 021823

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CARBONATE; RISEDRONATE SODIUM	EQ 500MG BASE;35MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021823

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

Labels for NDA 021823

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

Top