Drugs@FDA: FDA Approved Drug Products

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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
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

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
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-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-35 Labeling-Patient Package Insert, Labeling-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
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020690s036,021720s009,022568s006lbl.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
03/07/2012 SUPPL-35 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020690s035,021720s008,022568s005lbl.pdf
03/07/2012 SUPPL-35 Labeling-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 HEALTHCARE LTD
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 201724 ALEMBIC PHARMS LTD
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 078841 APOTEX
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 077518 CIPLA LTD
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 202114 CSPC OUYI PHARM CO
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 090521 MYLAN PHARMS INC
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 090425 PLIVA HRVATSKA DOO
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 200292 PRINSTON INC
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 090290 SANDOZ
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 203907 SCIEGEN PHARMS INC
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 090493 SUN PHARM INDS
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 076786 SUN PHARM INDS LTD
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 077344 TEVA
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 090686 TORRENT PHARMS
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 203656 UNICHEM LABS LTD
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 090551 VIVIMED GLOBAL
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 091267 WOCKHARDT
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 090100 ZYDUS PHARMS USA INC

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 HEALTHCARE LTD
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 201724 ALEMBIC PHARMS LTD
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 078841 APOTEX
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 077518 CIPLA LTD
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 202114 CSPC OUYI PHARM CO
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 090521 MYLAN PHARMS INC
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 090425 PLIVA HRVATSKA DOO
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 200292 PRINSTON INC
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 090290 SANDOZ
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 203907 SCIEGEN PHARMS INC
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 090493 SUN PHARM INDS
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 076786 SUN PHARM INDS LTD
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 077344 TEVA
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 090686 TORRENT PHARMS
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 203656 UNICHEM LABS LTD
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 090551 VIVIMED GLOBAL
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 091267 WOCKHARDT
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 090100 ZYDUS PHARMS USA INC

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