Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020690
Company: EISAI INC
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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/25/1996 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020690Orig1s000rev.pdf |
Supplements
| 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)
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-39 | 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-37 | 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-36 | Labeling-Patient Package Insert, Labeling-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-35 | 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 | |
| 12/02/2010 | SUPPL-33 | 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 | |
| 04/04/2013 | SUPPL-31 | 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 |
| 10/13/2006 | SUPPL-26 | 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 | |
| 01/07/2002 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/07/2002 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/03/2001 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/20/2001 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 09/21/2000 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/28/2000 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/28/2000 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 05/04/2004 | SUPPL-11 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20690slr011ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020690_s011_aricept.pdf |
| 08/18/1999 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/10/1999 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/28/2000 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 11/04/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/16/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/18/1998 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 08/13/1998 | SUPPL-4 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 08/13/1998 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| 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 |
ARICEPT
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ARICEPT | DONEPEZIL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | Yes | AB | 020690 | EISAI INC |
| DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 078662 | ACI |
| DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 201724 | ALEMBIC PHARMS LTD |
| DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 090056 | AUROBINDO |
| DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 204609 | CADILA PHARMS LTD |
| DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 090425 | CHARTWELL RX |
| DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 077518 | CIPLA LTD |
| DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 201001 | DR REDDYS LABS LTD |
| DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 203034 | HETERO LABS LTD V |
| DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 201634 | INDICUS PHARMA |
| DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 090768 | JUBILANT GENERICS |
| DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 201146 | MACLEODS PHARMS LTD |
| DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 200292 | PRINSTON INC |
| DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 202114 | RISING |
| DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 203907 | SCIEGEN PHARMS INC |
| DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 090551 | STRIDES PHARMA |
| DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 090686 | TORRENT PHARMS |
| DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 090100 | ZYDUS LIFESCIENCES |
TABLET;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ARICEPT | DONEPEZIL HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | Yes | AB | 020690 | EISAI INC |
| DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 078662 | ACI |
| DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 201724 | ALEMBIC PHARMS LTD |
| DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 090056 | AUROBINDO |
| DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 204609 | CADILA PHARMS LTD |
| DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 090425 | CHARTWELL RX |
| DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 077518 | CIPLA LTD |
| DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 201001 | DR REDDYS LABS LTD |
| DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 203034 | HETERO LABS LTD V |
| DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 201634 | INDICUS PHARMA |
| DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 090768 | JUBILANT GENERICS |
| DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 201146 | MACLEODS PHARMS LTD |
| DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 200292 | PRINSTON INC |
| DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 202114 | RISING |
| DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 203907 | SCIEGEN PHARMS INC |
| DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 090551 | STRIDES PHARMA |
| DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 090686 | TORRENT PHARMS |
| DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 090100 | ZYDUS LIFESCIENCES |