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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021169
Company: JANSSEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RAZADYNE GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET;ORAL Discontinued None Yes No
RAZADYNE GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET;ORAL Discontinued None Yes No
RAZADYNE GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET;ORAL Discontinued None Yes No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/03/2021 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021169s035,021615s026lbl.pdf
03/20/2020 SUPPL-34 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021169s034lbl.pdf
03/20/2020 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021169s034lbl.pdf
02/21/2020 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021169s033,021615s024lbl.pdf
02/14/2017 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021169Orig1s032,021224Orig1s030,021615Orig1s023lbl.pdf
12/15/2015 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021169s031-021224s029-021615s022lbl.pdf
02/09/2015 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021615s021lbl.pdf
06/28/2013 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021169s024,021224s022,021615s016lbl.pdf
03/01/2012 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021169s026,021224s025,021615s018lbl.pdf
03/01/2012 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021169s017,021224s015,021615s009lbl.pdf
03/01/2012 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021169s016,021224s014,021615s008lbl.pdf
02/28/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21169lbl.pdf
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