Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021224
Company: JANSSEN PHARMS
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RAZADYNE GALANTAMINE HYDROBROMIDE 4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION;ORAL Discontinued None No No
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.

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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