An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 090100
Company: ZYDUS LIFESCIENCES

Products on ANDA 090100

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090100

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/24/2012	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/05/2016	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
02/13/2015	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090100

DONEPEZIL HYDROCHLORIDE

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	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	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	090551	NOVITIUM PHARMA
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
DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	078662	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

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	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	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	090551	NOVITIUM PHARMA
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
DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	078662	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

Top