Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021720
Company: EISAI INC
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 | Discontinued | None | Yes | No |
ARICEPT ODT | DONEPEZIL HYDROCHLORIDE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | Yes | 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 |
---|---|---|---|---|---|---|---|
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 |
---|---|---|---|---|---|
12/18/2018 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020690s042,021720s014,022568s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021720Orig1s014, 022568Orig1s011, 020690Orig1s042ltr.pdf | |
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 |
---|---|---|---|---|---|
12/18/2018 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020690s042,021720s014,022568s011lbl.pdf | |
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 |