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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020690
Company: EISAI INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARICEPT DONEPEZIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription AB Yes Yes
ARICEPT DONEPEZIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription AB Yes No

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
12/18/2018 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020690s042,021720s014,022568s011lbl.pdf
07/20/2015 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020690s039,021720s012,022568s008lbl.pdf
09/06/2013 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020690s037,021720s010,022568s007lbl.pdf
09/04/2012 SUPPL-36 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020690s036,021720s009,022568s006lbl.pdf
09/04/2012 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020690s036,021720s009,022568s006lbl.pdf
03/07/2012 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020690s035,021720s008,022568s005lbl.pdf
03/07/2012 SUPPL-35 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020690s035,021720s008,022568s005lbl.pdf
12/02/2010 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022568s004,020690s033,021720s006lbl.pdf
10/13/2006 SUPPL-26 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020690s026,021720s003lbl.pdf
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