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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021224
Company: JANSSEN PHARMS

Other Important Information from FDA

Products on NDA 021224

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RAZADYNE	GALANTAMINE HYDROBROMIDE	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021224

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/22/2001	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21224lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21224ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-224_Reminyl.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/14/2017	SUPPL-30	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021169Orig1s032,021224Orig1s030,021615Orig1s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021169Orig1s032,021224Orig1s030,021615Orig1s023ltr.pdf
12/15/2015	SUPPL-29	Labeling, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021169s031-021224s029-021615s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021169Orig1s031,021224Orig1s029,021615Orig1s022ltr.pdf
02/09/2015	SUPPL-28	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021615s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021615Orig1s21,021169Orig1s30,021224Orig1s28ltr.pdf
05/21/2013	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
03/01/2012	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021169s026,021224s025,021615s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021169s026,021224s025,021615s018ltr.pdf
06/28/2013	SUPPL-22	Labeling, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021169s024,021224s022,021615s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021169Orig1s024,021224Orig1s022,021615Orig1s016ltr.pdf
03/01/2012	SUPPL-15	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021169s017,021224s015,021615s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021224s015,021169s017,021615s009ltr.pdf
03/01/2012	SUPPL-14	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021169s016,021224s014,021615s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021169s016,021224s014,021615s008ltr.pdf
04/27/2006	SUPPL-12	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021169s10s12s13s14,21224s8s10s11s12,21615s1s3s4s5LTR.pdf
04/27/2006	SUPPL-11	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021169s10s12s13s14,21224s8s10s11s12,21615s1s3s4s5LTR.pdf
04/27/2006	SUPPL-10	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021169s10s12s13s14,21224s8s10s11s12,21615s1s3s4s5LTR.pdf
05/02/2005	SUPPL-9	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021169s011,021224s009,021615s002ltr.pdf
04/27/2006	SUPPL-8	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021169s10s12s13s14,21224s8s10s11s12,21615s1s3s4s5LTR.pdf
09/03/2003	SUPPL-5	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21224slr005,21169slr007ltr.pdf
04/19/2002	SUPPL-3	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21169s003.pdf
04/24/2002	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 021224

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/14/2017	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021169Orig1s032,021224Orig1s030,021615Orig1s023lbl.pdf
12/15/2015	SUPPL-29	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021169s031-021224s029-021615s022lbl.pdf
12/15/2015	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021169s031-021224s029-021615s022lbl.pdf
02/09/2015	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021615s021lbl.pdf
06/28/2013	SUPPL-22	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021169s024,021224s022,021615s016lbl.pdf
06/28/2013	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021169s024,021224s022,021615s016lbl.pdf
03/01/2012	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021169s026,021224s025,021615s018lbl.pdf
03/01/2012	SUPPL-15	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021169s017,021224s015,021615s009lbl.pdf
03/01/2012	SUPPL-14	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021169s016,021224s014,021615s008lbl.pdf
06/22/2001	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21224lbl.pdf

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