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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201146
Company: MACLEODS PHARMS LTD

Products on ANDA 201146

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 201146

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/17/2012	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/07/2023	SUPPL-22	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide, Labeling-Patient Package Insert		Label is not available on this site.
11/13/2020	SUPPL-15	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
11/08/2016	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
11/06/2014	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
11/07/2013	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 201146

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	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	090493	SUN PHARM INDS
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	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	090493	SUN PHARM INDS
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

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