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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021615
Company: JANSSEN PHARMS

Other Important Information from FDA

Products on NDA 021615

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RAZADYNE ER	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
RAZADYNE ER	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
RAZADYNE ER	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021615

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/01/2005	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021615lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021615s000revLTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021615s000_RazadyneTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/26/2022	SUPPL-27	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021615s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021615Orig1s027ltr.pdf
08/03/2021	SUPPL-26	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021169s035,021615s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021169Orig1s035; 021615Orig1s026ltr.pdf
03/20/2020	SUPPL-25	Labeling-Container/Carton Labels, Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021615Orig1s025ltr.pdf
02/21/2020	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021169s033,021615s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021169Orig1s033; 021615Orig1s024ltr.pdf
02/14/2017	SUPPL-23	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-22	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-21	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-19	Manufacturing (CMC)		Label is not available on this site.
03/01/2012	SUPPL-18	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-16	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-9	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-8	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-5	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-4	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-3	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-2	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-1	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021169s10s12s13s14,21224s8s10s11s12,21615s1s3s4s5LTR.pdf

Labels for NDA 021615

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/26/2022	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021615s027lbl.pdf
08/03/2021	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021169s035,021615s026lbl.pdf
02/21/2020	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021169s033,021615s024lbl.pdf
02/14/2017	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021169Orig1s032,021224Orig1s030,021615Orig1s023lbl.pdf
12/15/2015	SUPPL-22	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021169s031-021224s029-021615s022lbl.pdf
12/15/2015	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021169s031-021224s029-021615s022lbl.pdf
02/09/2015	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021615s021lbl.pdf
06/28/2013	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021169s024,021224s022,021615s016lbl.pdf
06/28/2013	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021169s024,021224s022,021615s016lbl.pdf
03/01/2012	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021169s026,021224s025,021615s018lbl.pdf
03/01/2012	SUPPL-9	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021169s017,021224s015,021615s009lbl.pdf
03/01/2012	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021169s016,021224s014,021615s008lbl.pdf
04/01/2005	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021615lbl.pdf

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