Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021720
Company: EISAI INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARICEPT ODT DONEPEZIL HYDROCHLORIDE 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB Yes No
ARICEPT ODT DONEPEZIL HYDROCHLORIDE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/18/2004 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21720lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21720ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021720_s000_AriceptTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/20/2015 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020690s039,021720s012,022568s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022568Orig1s008,021720Orig1s012,020690Orig1s039ltr.pdf
09/06/2013 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020690s037,021720s010,022568s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020690Orig1s037,021720Origs010,022568Orig1s007ltr.pdf
09/04/2012 SUPPL-9 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020690s036,021720s009,022568s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020690Orig1s036,021720Orig1s009,022568Orig1s006ltr.pdf
03/07/2012 SUPPL-8 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020690s035,021720s008,022568s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022568s005,020690s035,021720s008ltr_corrected.pdf
04/04/2013 SUPPL-7 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021720Orig1s007,020690Orig1s031ltr.pdf
12/02/2010 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022568s004,020690s033,021720s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022568s004,020690s033,021720s006ltr.pdf
10/13/2006 SUPPL-3 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020690s026,021720s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020690s026,021720s003LTR.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/20/2015 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020690s039,021720s012,022568s008lbl.pdf
09/06/2013 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020690s037,021720s010,022568s007lbl.pdf
09/04/2012 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020690s036,021720s009,022568s006lbl.pdf
09/04/2012 SUPPL-9 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020690s036,021720s009,022568s006lbl.pdf
03/07/2012 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020690s035,021720s008,022568s005lbl.pdf
03/07/2012 SUPPL-8 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020690s035,021720s008,022568s005lbl.pdf
12/02/2010 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022568s004,020690s033,021720s006lbl.pdf
10/13/2006 SUPPL-3 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020690s026,021720s003lbl.pdf
10/18/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21720lbl.pdf

ARICEPT ODT

TABLET, ORALLY DISINTEGRATING;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ARICEPT ODT DONEPEZIL HYDROCHLORIDE 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021720 EISAI INC
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078388 BARR
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 201787 MACLEODS PHARMS LTD
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 091198 SANDOZ
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 204831 UNICHEM LABS LTD
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 090175 ZYDUS PHARMS USA INC

TABLET, ORALLY DISINTEGRATING;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ARICEPT ODT DONEPEZIL HYDROCHLORIDE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021720 EISAI INC
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078388 BARR
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 201787 MACLEODS PHARMS LTD
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 091198 SANDOZ
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 204831 UNICHEM LABS LTD
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 090175 ZYDUS PHARMS USA INC

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